This is a public health concern, argue the researchers, and they call for immediate improvements to better protect patient safety and meet FDA standards.

US regulations require medical device makers to report malfunctions and adverse events to the FDA’s Manufacturer And User Facility Device Experience (MAUDE) database within 30 days to inform safety measures, such as product recalls, as part of the postmarket surveillance process.

MAUDE requires complete and accurate reporting to be effective, but earlier programs, notably the Alternative Summary Reporting (ASR) programme, let manufacturers submit millions of adverse events as bulk summaries rather than as individual reports in order to “reduce the burden on industry.”

Although the FDA ended the ASR programme in 2019 due to concerns that it masked safety signals, similar summary reporting exemptions remain in use, but their accuracy, completeness, and compliance with FDA rules are unclear.

To address this, researchers analysed all adverse event summary reports submitted to MAUDE over a six-year period (July 2019 to June 2025) for evidence of incomplete device problem identification, undercounting of adverse events, failure to correctly identify reports as summary reports, and delays in serious adverse event reporting.

A total of 6,308 summary reports were submitted to the FDA during the study period containing 159,503 adverse events, mostly involving high risk devices.

Of these, 57% identified no device or use problem, 38% reported insufficient information, 11% were incorrectly identified as non-summary reports, 7% incorrectly listed one event in the ‘number of events’ field, and 55% exceeded the FDA’s 30-day reporting deadline.

The researchers acknowledge the inherent limitations of passive adverse event reporting and the lack of publicly available information on the specific requirements governing summary reporting exemptions.

However, they say identifying and correcting the existing flaws highlighted in this study are vital, particularly given that the number of summary reports submitted to the FDA – and the number of adverse events contained within them – more than doubled between 2020 and 2024.

“Immediate improvements are needed to better protect patient safety and adhere to transparency principles outlined by the FDA,” they write. “Making serious adverse event reports fully visible and accessible is critical to patient safety.”

In a linked editorial, Koji Todaka at Kyushu University Hospital in Japan, says these findings raise concerns about transparency in a system intended to support public scrutiny of medical device safety.

To preserve public trust in postmarket surveillance, he says regulators should require accurate and timely summary reporting, standardised device identification, and clear links to registries. He also suggests that researchers integrate spontaneous reports, registries, and linked healthcare data rather than treating any single source as definitive.

He also notes that the FDA is currently transitioning to a new Adverse Event Monitoring System (AEMS), designed to consolidate existing reporting systems and publish adverse event reports in real time.

“Transparency builds trust, evidence improves safety, and both are essential to effective postmarket surveillance and safer medical devices,” he concludes.

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The review compiled data from over 93 studies and included observed practices of millions of prescribers who had received either advertising and education, such as sales rep visits, gifts and payments, or free samples from pharmaceutical companies. The researchers found that these gift relationships and marketing tactics led physicians to more often prescribe the drugs a company was promoting. The data also showed that these marketing practices were strongly linked to inappropriate prescribing, meaning physicians were likely prescribing treatments that patients do not necessarily need, or that may cause harm.

Quinn Grundy is an associate professor at the Lawrence Bloomberg Faculty of Nursing and is one of the two Canadian authors involved in the review.  She points out that these marketing tactics employed by pharmaceutical companies are a common practice among physicians globally, with the same multi-national companies marketing their drugs worldwide.

“In the U.S., where companies are required to report payments made to physicians in a public database, just over half of all licensed physicians have accepted a payment, including free meals from a pharmaceutical company,” says Grundy, who is also the Director of the WHO Collaborating Centre for Governance, Accountability, and Transparency in the Pharmaceutical Sector located at the University of Toronto.  “This is important because it shows that companies are focusing their marketing resources on physicians who will deliver the highest return on investment, and prescribe more of their promoted drug, but it also shows that there are a large number of physicians who are choosing not to interact with pharmaceutical companies and remain independent of these influences.”

There were no Canadian studies included in the review, in part because Canada does not have a mechanism in place to track how much or why pharmaceutical companies are paying physicians or nurse practitioners. However, Grundy notes that according to surveys and qualitative research not included in this review, free meals and payments are likely common among Canadian prescribers.

“When physicians accept payments or free meals from the pharmaceutical industry we can see evidence in the data that physicians prescribe more of the promoted drug. This practice can increase the overall costs to our health system, and to patients through higher co-pays and out-of-pocket costs, when they are prescribed a brand name drug even though cost-effective alternatives exist,” says Grundy.

Grundy believes it is imperative that healthcare organizations, professional societies, and health professional schools be more aware of the influence of pharmaceutical industry promotion and address these through policy changes.

“Prescribers need independent, evidence-based sources of information to ensure their own independence in practice and to be trustworthy and accountable to the people they serve,” says Grundy.

Studies included in the review also examined the impact of conflict-of-interest policies or limitations on physician interactions with industry in the practice setting such as within medical schools and teaching hospitals. The review showed that in these instances, conflict-of-interest policies had a mitigating effect where physicians tended to prescribe less overall or prescribed more appropriate treatments. The review authors suggest that more robust conflict-of-interest policies would be an important way forward to reduce the influence of pharma on prescribers.

“These studies show that we can create practice environments that promote and preserve independence and that this is best achieved collectively, within health systems and institutions, rather than leaving it up to individual clinicians,” says Grundy.

While the available research focused on physicians in many health systems, including Canada, physicians are no longer the only prescribers. Other descriptive studies using the Open Payments data in the U.S., and which were not included in this review, found that advanced practice nurses, including nurse practitioners and clinical nurse specialists, are also targets of industry promotion.

“This is not just a problem for medicine, it affects the entire healthcare team,” says Grundy. “We need to create healthcare environments that safeguard the independence and integrity of care.”

DOI – 10.1002/14651858.CD013423.pub3

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The interview study explored pharmaceutical sector stakeholders’ views on how changes to EU chemicals legislation affect the green transformation in the sector, as well as their practices for supporting it. The interviewees came from seven European countries and worked in the pharmaceutical industry, industry associations, non-governmental organisations, public authorities and academia. The study was carried out as part of the PharGTrans project, funded by the Research Council of Finland.

Views among pharmaceutical sector stakeholders varied on how legislation affects the green transformation

“Many stakeholders in the pharmaceutical sector viewed the various legislative changes, such as the proposed restriction of PFASs under the REACH Regulation, and the Regulation on Packaging and Packaging Waste, as supporting the green transformation,” says Doctoral Researcher Sanja Riikonen of the University of Eastern Finland.

Pharmaceutical sector stakeholders found that these regulations encourage the development of environmentally less harmful compounds that could, in the future, replace substances of concern used in pharmaceutical production processes and increase the use of recycled materials in packaging. Changes aimed at improving information sharing and transparency, such as the regulation establishing a common data platform on chemicals, were likewise seen as supporting the green transformation in the pharmaceutical sector.

On the other hand, the stakeholders interviewed for the study felt that several of the changes also posed major challenges for the sector and questioned their contribution to advancing the green transformation.

“The restriction of PFASs under the REACH Regulation, together with the recast Urban Wastewater Treatment Directive and its extended producer responsibility scheme, prompted considerable discussion, particularly among interviewees from pharmaceutical companies and industry associations,” Riikonen notes.

Although the proposed restriction of PFASs does not apply to active pharmaceutical ingredients the pharmaceutical industry uses many PFAS-containing materials in its production processes. The interviewees viewed a rapid transition to alternative materials as challenging. The extended producer responsibility scheme under the Urban Wastewater Treatment Directive has direct implications for the pharmaceutical industry, as it requires the pharmaceutical and cosmetics industries to cover a large proportion of the costs associated with upgrading wastewater treatment processes in EU Member States. The interviewees found that requiring industry to bear these costs could divert companies’ resources and attention away from other measures that promote sustainability.

Greater collaboration is needed across sectors and among stakeholders

According to the study, closer collaboration between different policy sectors and stakeholder groups is needed in the legislative drafting process. Several stakeholders highlighted challenges arising from shortcomings in communication and a limited understanding of the broader picture across sectors. According to the interviewees, more transparent preparatory processes, better information-sharing and more inclusive dialogue could reduce inconsistencies between regulations affecting the chemicals, environmental and pharmaceutical sectors and promote more coherent decision-making.

“The effects of regulation supporting the green transformation on different stakeholders should also be taken into account more effectively. This could help to avoid unintended consequences of regulation that may even slow down the green transformation it is intended to advance,” Riikonen concludes.

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The EMA’s human medicines committee (CHMP) also backed extensions to the therapeutic indications of a further 11 medicines. The expert recommendations, made after extensive analysis of clinical information, must be formally approved by the European Commission.

The committee gave the green light for the following:

• Frehemgo (denecimig) for the prophylaxis of bleeding episodes in patients with haemophilia A.
• Gevalka (ensartinib) for the treatment of adult patients with anaplastic lymphoma kinase positive advanced non-small cell lung cancer.
• Klygefa (gefurulimab) for the treatment of adult patients with generalised myasthenia gravis.
• Lifyorli (relacorilant) for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Povofortay (povorcitinib) for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults.
• Sepalna (senaparib), a maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer.
• VaxRabeo (rabies virus (inactivated) strain WISTAR (PM/WI38 1503-3M)), a vaccine for pre-exposure and post-exposure prophylaxis against rabies in individuals of all age groups.
• Zeydovio (glepaglutide) for the treatment of short bowel syndrome

Two biosimilar medicines received a positive review:

• Adcomfo (omalizumab) for the treatment of asthma, chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria.
• Pebrilzo (pertuzumab), for the treatment of breast cancer in adults. Pebrilzo is the first biosimilar medicine recommended for approval following the tailored clinical approach.

Two generic medicines were also recommended:

• Inijaq (tofacitinib) for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis in adults, and juvenile idiopathic arthritis in children from two years of age.
• Ruxolitinib Zentiva (ruxolitinib) for the treatment of myelofibrosis in adults, polycythaemia vera in adults, and graft-versus-host disease in adults and children.

The CHMP recommended a change to the terms of the marketing authorisation for the medicinal product Anzupgo, used to treat moderate to severe chronic hand eczema in adults. The committee recommended lowering the age of administration to adolescents 12 years of age and older.

The committee also extended the indications for another 10 medicines that are already authorised in the European Union (EU): Abiraterone Mylan, Cosentyx, Enhertu, Jyseleca, Keytruda, Ocrevus, Padcev, Pepaxti, Sogroya, and Tecvayli.

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The pilot is part of EMA’s efforts to deepen regulatory acceptance of NAMs by enabling regulators to gain experience with these approaches and assess their scientific value in a regulatory context. NAMs can include complex in vitro systems, computational models, as well as a combination of multiple methodologies.

The Agency said this initiative will strengthen the future use of scientifically robust alternatives to animal testing in regulatory decision-making. It builds on EMA’s longstanding commitment to the 3Rs principles – to replace, reduce and refine the use of animals in medicines development and regulation.

Participants in the VDS pilot will receive individual feedback from an expert group comprising non-clinical experts from across the European medicines regulatory network.

Submissions to the VDS pilot are expected until the third quarter of 2027. At the end of the pilot, EMA will publish a lessons-learned report.

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The changes should benefit kids’ health, but may be challenging for schools to implement, according to a Stanford Medicine study.

“It’s easy to say, ‘Let’s remove ultra-processed foods from school meals,’ but school districts will likely face many challenges in implementing this policy,” said the study’s senior author, Anisha Patel, MD, professor of pediatrics at Stanford Medicine.

The research team’s work, to be published Sept. 28 in Public Health Nutrition, identified the top challenges that school food service directors expect to face. Budget constraints, limited staff, difficulty with food procurement and inadequate kitchen infrastructure were their biggest concerns, the study reports.

Lawmakers will likely need to direct more funding to school food budgets to help put the new legislation into practice, said lead study author Andrea Pedroza-Tobias, PhD. She was an instructor in pediatrics at Stanford Medicine when the study was conducted and is now an assistant professor in residence at the University of California, Irvine. “It’s an investment in the future of these kids. For many California children, two of the three meals they eat per day come from their schools.”

Evaluating barriers

The new California statute, AB 1264, aka the Real Food, Healthy Kids Act, requires elimination of certain ultra-processed foods considered harmful to children’s health from school menus by July 1, 2035. Several other states are considering similar legislation to reduce kids’ risk for obesity and related health problems, and the latest version of the Dietary Guidelines for Americans encourages people to consume fewer ultra-processed foods. The U.S. Department of Health and Human Services also recently announced a $32.5 million initiative to help school districts test how to deliver healthier food to students.

Ultra-processed foods can be defined in several ways. Researchers typically use the Nova classification: industrially created food with additives that enhance the item’s taste or convenience. The new California law uses a more specific definition, with more details about which food additives are prohibited and the balance of nutrients required. Heat-and-serve foods, flavored yogurt, frozen pizza and breakfast cereals are common examples of ultra-processed foods that currently appear on school menus.

The Stanford Medicine team, along with their colleagues, interviewed food service directors from 20 school districts in California’s San Joaquin Valley, an agricultural region with many low-income families whose students depend on school meals. In the interviews, the researchers asked participants to rate how much of a barrier they anticipated certain factors would be in eliminating ultra-processed menu items. The research team also asked open-ended questions to allow detailed responses about various challenges.

Fiscal and logistical challenges

One major category of challenge was fiscal. Eliminating ultra-processed foods — which are cheap and easy to heat and serve with minimal kitchen equipment — will strain budgets, food service directors said.

In 2021, California began providing meals to all K-12 public school students for free, regardless of families’ incomes. Federal and state funding reimburse districts around $4.60 per lunch served, and with more kids eating the meals, schools can now offer more and better menu choices.

“That has been something positive for school districts: Universal school meals increased participation, which brought more money to districts’ food service programs,” Pedroza-Tobias said.

But less-processed items will increase costs, likely outpacing existing budgets, and will make some foods harder to procure.

Amanda Harvey, director of nutrition services for the Fresno Unified School District, who was a member of the community advisory board for study, encountered these problems when her team eliminated products containing food dye from their menus.

For instance, it was difficult for her school district to purchase pickles made without green dye No. 5. “They’re pricey for pickles, and it can be quite challenging for our vendor to get them,” Harvey said. “So sometimes we have a shortage of pickles because of this food dye.”

Measures that reduce food costs may become harder for schools to use, the researchers noted. For instance, districts can purchase inexpensive commodity foods through the U.S. Department of Agriculture — such as raw chicken — which they may send to a food processor in exchange for easier-to-serve items such as chicken nuggets. “While this practice helps schools that don’t have the kitchen infrastructure for anything but ready-to-eat foods,” Pedroza-Tobias said, “it can inadvertently increase the amount of ultra-processed food on the menu.”

Food service directors also identified challenges related to school staffing and infrastructure. Many schools employ part-time staff to heat and serve foods; these individuals may not be trained to cook similar foods from scratch. Scratch cooking also takes more time, and moving staff from part-time to full-time jobs would require larger budgets for staff salaries and benefits.

Many schools lack fully equipped kitchens, and retrofits are difficult. Harvey’s team explored whether they could make sandwiches from scratch in some of the elementary schools in her district that have kitchens designed only for heat-and-serve meals. The local health department denied the request because the kitchens did not meet permitting standards for scratch cooking, she said.

“They said, ‘In order to get these 50 schools permitted, you would need to add new sinks, drains and hoods,’” Harvey said. This would have cost millions of dollars, which would have had to come from district infrastructure funds, not the cafeteria budget, she added. The Fresno school district has a central kitchen facility equipped for scratch cooking, so Harvey’s team opted to make sandwiches there instead, but smaller school districts may lack that option.

Student preferences may also be a challenge, although some food service directors reported that students like certain fresh menu items. Harvey’s district works with chefs in developing scratch-made items they can add to their menus. Students also appreciate having more options on the menu, she said, adding that when her district began offering menu choices at elementary schools, “We definitely saw a huge decrease in parent and student complaints.”

Strategies for change

The research team also heard about how some districts have addressed these concerns. Some have bridged fiscal gaps with grant funding, although participants said that “if they get this funding for one year, and are not sure they’ll have the same money next year, they don’t feel like they can make sustainable changes,” Pedroza-Tobias said. Applying for grants also requires staff time, putting smaller districts with fewer support staff members at a disadvantage.

One district succeeded in making most of its food from scratch, in part because the food service director was a chef who also had a background in nutrition. “They also did a lot of engagement with families and students to increase the acceptance of scratch-cooked meals,” Pedroza-Tobias said. “For instance, they had a junior chef competition where students submitted a recipe, and they selected some of these recipes to cook in the school kitchen.”

The researchers hope their findings will help legislators and school districts navigate the challenges of serving healthier school meals, she said. Patel added, “Moving from ultra-processed food to scratch cooking requires an upfront investment, but healthier school meals can pay off in the long term by preventing health care costs associated with diseases such as obesity, Type 2 diabetes and cardiovascular disease.”

Researchers from the Dolores Huerta Foundation, Cultiva la Salud, and the Nutrition Policy Institute of the University of California Agriculture and Natural Resources contributed to the study.

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (grant P30DK092924); the National Heart, Lung, and Blood Institute (grant K24HL169841); Stanford’s Maternal and Child Health Research Institute; the William and Nancy Thompson Family Foundation; and Stanford Impact Labs.

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The cycle also includes two significant first-in-class or novel-mechanism approvals: a subcutaneous formulation of ocrelizumab for multiple sclerosis offering a faster administration option compared with the established intravenous infusion, and gefurulimab, a new complement inhibitor for myasthenia gravis. Rheumatology features prominently, with filgotinib receiving two separate recommendations for related but distinct forms of spondyloarthritis in the same cycle.

Oncology

Enhertu recommended for HER2-positive breast cancer

Fam-trastuzumab deruxtecan (Enhertu), developed by Daiichi Sankyo and AstraZeneca, received a CHMP recommendation on 18 September 2026 for HER2-positive breast cancer. Enhertu is a HER2-directed antibody-drug conjugate that has transformed the treatment landscape across multiple HER2-expressing tumour types. This recommendation reflects the continued expansion of its approved indications in breast cancer, building on earlier approvals for HER2-low and HER2-ultralow disease. The drug’s high drug-to-antibody ratio and membrane-permeable payload contribute to a bystander effect that may benefit tumours with heterogeneous HER2 expression.

Keytruda and Padcev combination recommended for muscle-invasive bladder cancer

Pembrolizumab (Keytruda) in combination with enfortumab vedotin (Padcev), submitted by Merck, Astellas, and Pfizer, received a CHMP recommendation on 18 September 2026 for muscle-invasive bladder cancer. This combination pairs a PD-1 checkpoint inhibitor with a Nectin-4-directed antibody-drug conjugate, targeting both immune evasion and tumour cell proliferation. The recommendation follows strong clinical evidence supporting this chemotherapy-free regimen as a front-line treatment option, extending its reach in urothelial cancer beyond the metastatic setting in which it was first established.

Ensacove recommended for ALK-positive non-small cell lung cancer

Ensartinib (Ensacove), an ALK inhibitor developed by Xcovery and Betta Pharmaceuticals, received a CHMP recommendation on 17 September 2026 for ALK-positive non-small cell lung cancer (NSCLC). ALK rearrangements are present in approximately three to five per cent of NSCLC cases and define a molecularly distinct subgroup that is highly sensitive to ALK-directed therapy. Ensartinib is a next-generation ALK inhibitor with activity against several resistance mutations that limit the efficacy of earlier agents in this class, offering an additional treatment option in a landscape already served by crizotinib, alectinib, brigatinib, and lorlatinib.

Tecvayli recommended for multiple myeloma

Teclistamab (Tecvayli), a BCMA/CD3 bispecific T-cell engager developed by Janssen Biotech, received a CHMP recommendation on 17 September 2026 for relapsed or refractory multiple myeloma. Tecvayli redirects cytotoxic T cells to BCMA-expressing myeloma cells, offering a chemotherapy-free immunological approach for patients who have exhausted prior lines of therapy. The recommendation adds to an increasingly complex therapeutic landscape in myeloma, which now includes proteasome inhibitors, immunomodulatory drugs, anti-CD38 monoclonal antibodies, BCMA-directed ADCs, and CAR-T therapies.

Pepaxto recommended for multiple myeloma

Melflufen in combination with dexamethasone (Pepaxto), developed by Oncopeptides, received a CHMP recommendation on 17 September 2026 for relapsed or refractory multiple myeloma. Melflufen is a peptide-drug conjugate that is selectively taken up by myeloma cells and cleaved intracellularly to release a cytotoxic alkylating agent. The agent targets a patient population with heavily pretreated, late-line disease, and its approval provides an additional option where treatment choices are often limited by prior exposure and resistance to established drug classes.

Lifyorli and Abraxane combination recommended for ovarian cancer

Relacorilant in combination with nab-paclitaxel (Lifyorli and Abraxane), submitted by Corcept Therapeutics, received a CHMP recommendation on 18 September 2026 for platinum-resistant ovarian cancer. Relacorilant is a selective glucocorticoid receptor modulator that blocks the pro-survival signalling that glucocorticoids can induce in tumour cells, potentially overcoming a mechanism of resistance to taxane-based chemotherapy. The combination represents a novel approach to a cancer type in which platinum resistance is a significant clinical challenge, and where effective second-line options remain limited.

Sepalna recommended for ovarian cancer

Senaparib (Sepalna), a PARP inhibitor developed by IMPACT Therapeutics and partnered with SFL Pharmaceuticals, received a CHMP recommendation on 17 September 2026 for ovarian cancer. PARP inhibitors exploit deficiencies in DNA repair pathways — particularly homologous recombination deficiency associated with BRCA mutations — to selectively kill cancer cells. Sepalna adds to an established class that includes olaparib, niraparib, and rucaparib, and its approval provides a further PARP inhibitor option for eligible patients across the ovarian cancer treatment continuum.

Rheumatology & Immunology

Jyseleca recommended for ankylosing spondylitis and axial spondyloarthritis

Filgotinib (Jyseleca), a selective JAK1 inhibitor developed by Eisai and Alfasigma, received two separate CHMP recommendations on 17 September 2026: one for ankylosing spondylitis (AS) and a second for non-radiographic axial spondyloarthritis (nr-axSpA), together covering the full spectrum of axial spondyloarthritis. AS is the radiographically confirmed form of axial SpA characterised by structural changes to the sacroiliac joints and spine, while nr-axSpA describes the earlier or less structurally severe presentation. The dual recommendation reflects the breadth of filgotinib’s clinical evidence across these related conditions, extending its established use in rheumatoid arthritis and ulcerative colitis into a further inflammatory rheumatological indication.

Cosentyx recommended for polymyalgia rheumatica

Secukinumab (Cosentyx), an anti-interleukin-17A monoclonal antibody developed by Novartis, received a CHMP recommendation on 18 September 2026 for polymyalgia rheumatica (PMR). PMR is a common inflammatory condition in older adults causing pain and stiffness in the shoulders, neck, and hips, and is currently managed primarily with long-term corticosteroid therapy, which carries significant cumulative side effects. Secukinumab is already approved for multiple immune-mediated inflammatory conditions including psoriasis, ankylosing spondylitis, and psoriatic arthritis; this recommendation in PMR represents a meaningful addition for a patient group in which steroid-sparing treatments are greatly needed.

Dermatology

Anzupgo recommended for atopic dermatitis

Delgocitinib (Anzupgo), a pan-JAK inhibitor developed by Japan Tobacco and Leo Pharma in a topical formulation, received a CHMP recommendation on 17 September 2026 for moderate to severe atopic dermatitis in adults. Topical JAK inhibitors represent an emerging class in atopic dermatitis that offer targeted anti-inflammatory activity at the site of application while minimising systemic exposure. Delgocitinib inhibits all four JAK isoforms and has demonstrated efficacy in patients with disease inadequately controlled by topical corticosteroids, providing a steroid-sparing alternative for chronic or difficult-to-manage disease.

Povofortay recommended for hidradenitis suppurativa

Povorcitinib (Povofortay), a selective JAK1 inhibitor developed by Incyte Corporation, received a CHMP recommendation on 17 September 2026 for hidradenitis suppurativa (HS), a chronic inflammatory skin condition characterised by recurrent painful nodules, abscesses, and scarring in the axillae, groin, and other intertriginous areas. HS is frequently debilitating and has historically been difficult to treat, with biologics targeting TNF-alpha and IL-17 offering only partial responses in many patients. Povorcitinib provides the first oral JAK inhibitor option in HS and may address patients who have an inadequate response to or cannot tolerate existing biologic therapies.

Neurology & Immunology

Ocrevus subcutaneous formulation recommended for multiple sclerosis

A subcutaneous formulation of ocrelizumab (Ocrevus SC), developed by Roche, Biogen, and Genentech, received a CHMP recommendation on 17 September 2026 for relapsing and primary progressive multiple sclerosis. Ocrelizumab is a CD20-directed B-cell depleting monoclonal antibody already widely used in its intravenous form, which requires administration by healthcare professionals in a clinical setting over several hours. The subcutaneous formulation offers a faster injection that may be suitable for home or self-administration in eligible patients, representing a meaningful advance in convenience and healthcare resource use without compromising efficacy.

Klygefa recommended for myasthenia gravis

Gefurulimab (Klygefa), a complement C2 inhibitor developed by Alexion Pharmaceuticals and AstraZeneca, received a CHMP recommendation on 18 September 2026 for generalised myasthenia gravis. Complement pathway inhibition is an established mechanism in myasthenia gravis, with anti-C5 agents already approved in this setting. Gefurulimab targets C2, an upstream component of both the classical and lectin pathways, offering a potentially broader complement blockade. The recommendation adds a further mechanistic option to a disease area that has seen rapid therapeutic development in recent years.

Haematology & Paediatrics

Frehemgo recommended for haemophilia A

Denecimig (Frehemgo), a novel bispecific antibody developed by Novo Nordisk, received a CHMP recommendation on 17 September 2026 for haemophilia A, including in paediatric patients. Denecimig mimics the cofactor function of factor VIII by bridging activated factor IX and factor X, enabling the coagulation cascade to proceed in the absence of endogenous factor VIII. The approach offers an alternative to factor replacement therapy that may be particularly valuable for patients with inhibitors — antibodies that neutralise infused factor VIII and render standard replacement therapy ineffective. The once-weekly subcutaneous administration route also offers a practical advantage over intravenous factor concentrate infusions.

Adcomfo biosimilar recommended for allergic asthma, urticaria, and nasal polyps

Adcomfo, a biosimilar of omalizumab developed by Alvotech and Advanz Pharma, received a CHMP recommendation on 17 September 2026 for allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps. Omalizumab is an anti-IgE monoclonal antibody that reduces the allergic inflammatory response and is already established across these three indications in its originator form (Xolair). As the first omalizumab biosimilar to receive a CHMP recommendation, Adcomfo is expected to increase competition in the market and improve patient access by reducing treatment costs across EU healthcare systems.

Ophthalmology

Susvimo implant recommended for age-related macular degeneration

The ranibizumab 100 mg/mL intravitreal implant (Susvimo), developed by Genentech/Roche and Novartis, received a CHMP recommendation on 21 September 2026 for neovascular (wet) age-related macular degeneration (AMD). Susvimo is a surgically implanted ocular device that delivers a continuous, sustained release of ranibizumab directly into the vitreous, avoiding the need for frequent intravitreal injections that characterise standard anti-VEGF therapy for wet AMD. The recommendation, which mirrors a decision also taken at the EU level this cycle, positions Susvimo as a long-term management option for patients with wet AMD who would benefit from a reduced injection burden.

Gastroenterology

Zeydovio recommended for short bowel syndrome

Glepaglutide (Zeydovio), a long-acting GLP-2 receptor agonist developed by Zealand Pharma, received a CHMP recommendation on 18 September 2026 for short bowel syndrome (SBS) in adults. SBS is a rare and debilitating condition resulting from the surgical removal or congenital absence of a significant portion of the small intestine, leaving patients dependent on parenteral nutrition for survival. GLP-2 receptor agonists promote intestinal adaptation by stimulating mucosal growth and improving absorptive capacity, with the goal of reducing or eliminating dependence on parenteral nutrition. Glepaglutide’s once-weekly dosing schedule, made possible by its extended half-life, offers a significant practical advantage over the twice-daily injections required with teduglutide, the existing approved GLP-2 analogue in this indication.

Infectious Diseases

VaxRabeo recommended for rabies prevention

VaxRabeo, an inactivated rabies vaccine developed by Sanofi Winthrop Industrie, received a CHMP recommendation on 17 September 2026 for the pre- and post-exposure prevention of rabies. Rabies remains a significant cause of mortality globally, particularly in parts of Asia and Africa, and EU travellers to endemic regions require access to reliable pre-exposure prophylaxis. The recommendation for VaxRabeo adds to the existing portfolio of approved rabies vaccines available within the EU and ensures continued supply of this important public health intervention.

All nineteen decisions listed carry CHMP Recommended status and were issued between 17–21 September 2026. CHMP recommendations are subject to final marketing authorisation by the European Commission. This article is based on data from the European Medicines Agency CHMP opinion cycle.

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The single negative decision — for nemolizumab in prurigo nodularis — reflects the ongoing challenge of demonstrating cost-effectiveness for treatments targeting rare and highly burdensome skin conditions, despite clear clinical evidence of benefit.

Positive Recommendations

Gomekli recommended for neurofibromatosis type 1 — a first approved treatment

Mirdametinib (Gomekli), developed by Springworks Therapeutics and MerckKGaA, received a positive NICE recommendation on 16 September 2026 for neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas in adults and children. NF1 is a rare inherited genetic condition caused by mutations in the NF1 tumour suppressor gene, leading to uncontrolled cell growth in nerve tissue. Plexiform neurofibromas are benign but often disfiguring and functionally impairing tumours that can cause chronic pain, neurological deficits, and airway compression depending on their location, and have historically been managed primarily through surgery. Mirdametinib is a selective MEK1/2 inhibitor that targets the RAS/MAPK signalling pathway activated by loss of neurofibromin, the protein encoded by the NF1 gene. The recommendation represents a landmark moment for the NF1 community, providing the first approved oral systemic therapy for this manifestation of the condition on the NHS.

Imfinzi combination recommended for endometrial cancer

Durvalumab (Imfinzi) in combination with carboplatin and paclitaxel chemotherapy, with or without olaparib (Lynparza), was recommended by NICE on 9 September 2026 for advanced or recurrent endometrial cancer. Submitted by AstraZeneca, this regimen reflects the emerging stratified approach to endometrial cancer treatment, in which the addition of a PARP inhibitor such as olaparib is directed at patients whose tumours show homologous recombination deficiency or specific molecular features. Durvalumab is a PD-L1 checkpoint inhibitor that augments the anti-tumour immune response alongside the cytotoxic effects of platinum-based chemotherapy. The recommendation positions this combination as a new standard-of-care option in a disease where systemic treatment outcomes have historically been poor in the relapsed or advanced setting.

Imbruvica plus R-CHOP recommended for mantle cell lymphoma

Ibrutinib (Imbruvica) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP), submitted by AbbVie and Janssen Biotech, received a positive NICE recommendation on 23 September 2026 for previously untreated mantle cell lymphoma (MCL) in adults who are eligible for intensive chemotherapy. MCL is an aggressive B-cell non-Hodgkin lymphoma with a tendency to relapse and a historically poor long-term prognosis despite initial responsiveness to treatment. Adding ibrutinib — a Bruton’s tyrosine kinase inhibitor — to the established R-CHOP immunochemotherapy backbone targets both the B-cell receptor signalling pathway and the tumour’s microenvironment. Clinical evidence has demonstrated improved progression-free survival with the ibrutinib-containing regimen in younger, transplant-eligible patients, and the recommendation opens this intensified approach to eligible NHS patients for the first time.

Negative Decision

Mitchga not recommended for prurigo nodularis

NICE issued a negative recommendation on 9 September 2026 for nemolizumab (Mitchga), an anti-interleukin-31 receptor A monoclonal antibody developed by Galderma, Chugai/Roche, and Maruho, for the treatment of prurigo nodularis. Prurigo nodularis is a chronic and severely distressing dermatological condition characterised by intensely itchy nodules distributed across the body, driven by a neuroimmune inflammatory mechanism in which IL-31 plays a central role. The condition causes profound impairment of quality of life and has very limited licensed treatment options, making the negative decision a significant disappointment for affected patients.

Nemolizumab has demonstrated clinically meaningful reductions in itch intensity and lesion burden in pivotal trials, and is approved in other markets including the United States and Japan. NICE’s negative determination is likely to reflect concerns regarding cost-effectiveness at the submitted price rather than a lack of clinical efficacy. The decision may be subject to further negotiation or resubmission, and patients and clinicians will be watching closely for any appeal or managed access arrangement that could bring this treatment to NHS patients in the future.

Decisions referenced carry NICE Positive 1 or NICE Negative status, issued between 9–23 September 2026. This article is based on data from the NICE Technology Appraisal Programme for England and Wales.

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A new study in Management Science finds that a human-plus-algorithm approach could help the FDA focus its limited review resources on medical devices whose safety is harder to assess, while potentially reducing future recalls. The study found that FDA could catch more unsafe devices and spend less time on the ones that don’t need scrutiny, with a 40.5% reduction in review workload, 32.9% improvement in the recall rate–FDA’s current recall rate is 10.3%–and up to an estimated $1.7 billion in annual healthcare savings from fewer device replacements.

Researchers from Indiana University, Harvard Kennedy School, and Emerging Health Consulting built a tool that flags which submissions are safe bets, which are risky enough to reject after a short scrutiny, and which need more careful human expert consideration. The machine-learning system estimating recall risk, and coupled with a data-driven policy, recommends which medical devices could be cleared or rejected algorithmically with minimal human oversight and which cases should be flagged for in-depth human review.

“AI is most useful in this setting when it works alongside human judgment, not when it tries to replace it,” said Soroush Saghafian, co-author. “An algorithm can systematically identify patterns in thousands of devices and their predicate histories, but there will always be cases where the evidence is ambiguous, or the stakes are too high for an automated decision. By reserving those cases for expert review, the FDA can use its human expertise where it matters most while making the overall process more efficient.”

The system works with predicate devices, or devices that may look similar enough, or “substantially equivalent,” to an existing approved device on the market that regulators could be reasonably confident is safe and effective. Researchers sought to make the comparison system more informative by looking systematically at the history of predicate devices, particularly how old the predicate devices were and their recall status, to estimate the likelihood that the new device would eventually be recalled.

For the devices, an optimization model set thresholds in an algorithm for three categories: devices that could be cleared, devices that may carry a high enough risk to be rejected and devices in between that should be reviewed by human experts, balancing the goal of identifying potentially unsafe devices with the FDA’s limited review capacity.

“Right now, the FDA has to devote substantial resources to reviewing medical devices even when the available evidence suggests they pose relatively little risk,” said Mohammad Zhalechian, lead author. “Our results suggest that a data-driven approach could help distinguish the straightforward cases from the ones that deserve a closer look. The goal isn’t to replace FDA reviewers—it’s to give them better information about where their time and expertise can have the greatest impact.”

The study and its findings coincide with an existing regulatory conversation. In 2023, the FDA put out a draft guidance about predicate selection best practices, proposing to evaluate predicate devices based on safety track record rather than just availability. The study’s model speaks directly to that proposal by tracking predicate recall history and age, a safety track record that the FDA’s own guidance pushes for. If tools like this can inform the direction the FDA takes, the result could be more safety, more efficient use of resources, and more money saved.

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• The majority of respondents (61.5%) reported a lack of awareness of best practices for providing non-English medication instructions to patients or pharmacies.
• Most (80.5%) did not know whether the pharmacy provided translated labels.
• Only 5.9% used the prescription’s free-text field to flag the need.
• More than one-fourth of prescribers (27.8%) were unsure whether the pharmacy received their communications about instruction translation.
• Few respondents (8.3%) informed patients that they could request non-English medication instructions from their pharmacy.
• Many prescribers (69.8%) doubted their patients got accurate written instructions.
• The obstacles named most often were time constraints (69.2%), lack of translation resources (62.7%), reaching interpreters between visits (51.5%) and inability to use a non-Latin alphabet (40.8%).

Why It Matters: These findings highlight the critical need to coordinate language services between institutions and among patients, prescribers, and pharmacy team members.

Prescriber Practices and Barriers to Providing Prescription Medication Instructions for Patients With a Non-English Language Preference

Corresponding Author: Beatriz Manzor, PharmD, BCPS, et al

University of Michigan College of Pharmacy, University of Michigan, Ann Arbor, Michigan

Permanent link

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Six of the 19 members of the Scientific Advisory Committee on Nutrition (SACN) have conflicts of interest that its own rules deem ‘significant’ and should preclude them from being appointed, reports freelance journalist Sophie Borland.

SACN is a powerful group of experts that provides nutritional advice to the government on issues including artificial sweeteners, ultra-processed foods, and dietary guidelines for babies, young children and the over 65s. Their reports are used to inform national policy as well as NHS healthy eating recommendations.

One SACN adviser was until recently a long-serving senior member of the British Nutrition Foundation – a charity funded by firms including Coca Cola, Nestlé, and Mondelez, parent company of Cadbury’s.

Four other advisors have received research funding from the meat, dairy and nut industries, including one who has also taken a grant from Danone, the world’s largest yoghurt maker.

Today’s figures come two years after an initial investigation by The BMJ revealed that more than half of SACN’s advisors at the time had ties to the food industry.

The BMJ’s findings were highlighted in a major House of Lords report into diet and obesity and, last September, SACN updated its code of practice to state that “individuals are only eligible to be SACN members if they do not hold significant interests in relation to the food, drink, diet or supplement industry.”

A spokesperson for the Department of Health and Social Care (DHSC) explained that current SACN advisors must not take on any new interests that are “at odds” with the updated policy, and can only be reappointed if they meet the updated policy.

“All SACN members are due to meet the new interests policy within the next two years,” they added. “In the meantime, existing members with any significant interests are excluded from relevant discussions.”

But experts argue that scientists with financial ties to the food industry should not be involved in influencing policy and have called for the conflicts to be removed “immediately”. Some said that at least some previous financial relationships should also rule out involvement even once lapsed.

The BMJ analysed SACN’s latest register of interests, published in June 2026, and found that six of the members declared “significant” conflicts of interest that the committee itself highlights with a note next to the declaration.

A further three were recorded by SACN as having “relevant” interests to the food industry, which are considered less serious. This includes receiving research funding from or undertaking consultancy work with smaller food firms.

The BMJ also identified other potentially serious conflicts of interests not flagged by SACN. This includes one advisor who is a “distinguished fellow” of the American Society for Nutrition, an organisation funded by organisations including Mondelez, Nestle and Pepsico. Five other members are on the UK’s Nutrition Society, which receives sponsorship from Pepsico for conferences.

Chris van Tulleken, a professor of infection and global health at University College London and author of the book Ultra-Processed People, says: “This is not an allegation that individual members are acting improperly or deliberately influencing SACN’s conclusions. However, research shows that conflicts of interest do affect beliefs and behaviour, as well as eroding trust in decision-making and advice.”

He adds: “The problem is structural. SACN’s authority depends on its independence, and these interests weaken public confidence and confer credibility on commercial actors that harm human health and scientific integrity.”

Rob Percival, head of policy at food and farming charity the Soil Association, welcomed the tightening of SACN’s policy but said it needs to be applied robustly. “I would suggest that the conflicted members of SACN need to leave the committee immediately and there needs to be open recruitment for non-conflicted members to stand in their place through an appropriate process.”

SACN’s updated rules allow members to stay on if they drop their significant conflict of interest, regardless of how long they had been working with the food industry beforehand or how much money they received.

But Percival argues that “once a scientist has received funding in relation to a product or is in a financial relationship with a manufacturer they should not be involved in policy making or regulatory decisions that pertain to that product.”

The BMJ’s findings come as SACN is working on recommendations on nutrition and maternal health, vitamin D requirements, and infant feeding. At its June meeting it considered whether to make new recommendations on topics including ultra-processed foods, artificial sweeteners, protein intake, and wholegrain foods, and agreed to keep these on its “watching brief.”

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The authors recommend nationwide adoption of ACN and advanced automatic crash notification (AACN), along with a standardized approach to share and interpret crash data among automakers, emergency responders, trauma experts, and federal agencies.

ACN alerts emergency responders after a serious collision. It can provide the vehicle’s location and, in many systems, establish voice communication between an operator and the people inside the vehicle. AACN systems also transmit detailed crash information that helps emergency responders estimate injury severity before arriving at the scene. The paper draws on prior research, including National Highway Traffic Safety Administration modeling that estimated AACN systems could save between 360 and 721 lives each year.

“Seat belts and air bags are standard because they are safety features, not luxury services. Automatic crash notification should be treated the same way,” said lead author Theresa L. Chin, MD, MPH, FACS, a trauma and burn surgeon at UCI Health. “In a serious crash, the system can tell EMS where the crash happened and provide early signs on the severity of crash and potential for significant injury. That can help the right resources start moving sooner, especially in rural communities where help may be farther away.”

Minutes Matter After a Serious Crash

Longer delays between a crash and notification of emergency medical services have been associated with a greater risk of death, particularly in rural areas. ACN can shorten that interval by automatically reporting the crash, its location, the time of the crash, even if occupants are unconscious, disoriented, or otherwise unable to call 911. AACN can add vehicle telemetry (data such as the change in vehicle speed, rollover, airbag deployment, and restraint status) to provide an early estimate of how likely there is to be severe injury.

Information showing that a vehicle rolled over several times may prompt a different response than a low-speed collision. Information on seat belt use and two-way communication with occupants may help responders determine how many people are involved and whether multiple ambulances are needed. The data may support decisions about deploying specialized trauma care such as advanced life support units, air medical transportation, extrication equipment (for example, the “jaws of life”), or direct transport to a trauma center.

Safety Technology Should Not Be Bundled with Convenience Features

Many ACN systems are packaged with paid connected-vehicle services such as remote start, door locking, mobile Wi-Fi, roadside assistance, or concierge features. As a result, drivers may unknowingly lose crash notification when a complimentary trial ends or when they cancel a package of services they don’t otherwise use.

Dr. Chin said she discovered, while working on the project, that ACN in her own family’s vehicle was no longer active because the bundled subscription had not been renewed. In fact, at a conference in a room of trauma professionals, “only one person knew that their vehicle had an active crash notification service,” she added.

The European Union has required inclusion of an emergency notification system known as eCall in all new vehicles since March 2018. The system automatically contacts emergency services following a serious crash and does not require a paid subscription.

How Drivers Can Check Their Vehicle

Drivers can take several steps to determine whether their current vehicle has ACN or AACN:

1. Search the owner’s manual or manufacturer’s app for terms such as “automatic crash notification,” “emergency call,” “connected services,” “911 assist,” “eCall,” or “SOS.”
2. Look for an SOS or emergency button, often located near the rearview mirror or overhead console. The presence of a button is a clue, but drivers should still confirm that the service is activated.
3. Check whether the system requires a paired phone or an active subscription. Some systems use a built-in cellular connection, while others work only when the driver’s phone is connected through Bluetooth.
4. Use the vehicle identification number (VIN) when contacting the manufacturer or dealership to confirm whether ACN or AACN was included in that specific model, model year, and options package.

“Most people assume that the safety systems built into their vehicle will be available when they need them,” Dr. Chin said. “Drivers should not have to discover after a serious crash that an emergency feature was tied to a premium service they stopped paying for.”

ACS Calls for Standard Access and Better Data Sharing

The ACS COT has previously issued a statement supporting:

• Making ACN and AACN standard in all new motor vehicles without additional subscription fees, while improving availability and connectivity in rural areas with limited cellular coverage.
• Developing reliable pathways for crash information to reach 911 centers and emergency response systems, with more consistent technical standards across automakers.
• Making ACN and AACN data available for research by injury prevention scientists and trauma system experts studying crashes, EMS response times, and injury patterns.
• Supporting federal research and collaboration with National Highway Traffic Safety Administration and other organizations to better understand how vehicle data can improve communication among 911 centers, EMS agencies, and hospitals.

The authors of the JACS’ paper also emphasize the need for common definitions across manufacturers. A notification that describes a crash as having a “high risk” of severe injury should have a consistent and clinically useful meaning regardless of whether the vehicle was made by one automaker or another. Standardization could help emergency responders and clinicians use the information more efficiently, particularly in communities with limited personnel, transportation, or hospital resources.

“Injury prevention does not end when a crash occurs; it also means reducing the harm that follows,” said co-author Leah C. Tatebe, MD, FACS, chair of the ACS COT Injury Prevention Program Area and associate professor of surgery at Northwestern University Feinberg School of Medicine. “This information could close a dangerous gap between time of crash and treatment. That protection should be built into every new vehicle, not reserved for people who can afford an ongoing subscription.”

Co-authors are Julie Y. Valenzuela, MD, FACS; Thomas Duncan, DO, FACS; Peter E. Fischer, MD, FACS; Alexandra Briggs, MD, FACS; Alexis Moren, MD, MPH, FACS; David S. Shapiro,MD, MHCM, MEd, CPHQ, FCCM, FACS; Anne Rizzo, MD, FACS, DABS; Haley Etskovitz, DO, MBS; Leah C. Tatebe, MD, FACS; Brendan T. Campbell, MD, MPH, FACS; and Eileen Bulger, MD, FACS.

This study is published as an article in press on the JACS website.

Citation: Chin TL, Valenzuela JY, Duncan T, et al. Advanced Automatic Crash Notification Systems: It Is Time to Adopt Potentially Life-Saving Technology. Journal of the American College of Surgeons, 2026. DOI: 10.1097/XCS.0000000000002168

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