Drawing on a large and diverse national sample, researchers found that formulary rejections occurred frequently and, in many cases, resulted in treatment being delayed or never received at all. The findings underscore the persistent tension between efforts to control drug spending and patients’ ability to obtain the medications their clinicians prescribe.

Single-source branded drugs—medications available from only one manufacturer with no generic equivalent—can be particularly vulnerable to access problems when insurers decline to cover them under their formularies, the lists of drugs a health plan agrees to pay for.

The authors say the results highlight the real trade-offs patients face between cost and access, and point to the need for closer scrutiny of how formulary decisions affect the people who depend on these treatments.

The study was led by corresponding author Joseph F. Levy, PhD, of Johns Hopkins University. Additional details, including author affiliations, conflict of interest disclosures, and funding sources, are available in the full article (doi:10.1001/jama.2026.8702).

The June cycle also includes a significant update to the existing recommendation for nusinersen in spinal muscular atrophy, as well as a positive second appraisal for a CAR-T cell therapy in large B-cell lymphoma — a treatment pathway that continues to expand within the NHS.

Oncology

Tivdak recommended for cervical cancer

Tisotumab vedotin (Tivdak), an antibody-drug conjugate developed by Genmab and Pfizer (via Seagen), received a positive NICE recommendation on 11 June 2026 for previously treated recurrent or metastatic cervical cancer. Tivdak targets tissue factor, a protein highly expressed on cervical cancer cells, and delivers a microtubule-disrupting payload directly to tumour cells. The approval addresses a population with limited options following progression on first-line platinum-based chemotherapy.

Libtayo recommended for non-small cell lung cancer

Cemiplimab (Libtayo), developed by Regeneron, was recommended on 16 June 2026 for previously untreated non-small cell lung cancer (NSCLC) in patients whose tumours express PD-L1. Libtayo is a PD-1 checkpoint inhibitor that restores the immune system’s ability to recognise and destroy cancer cells. The recommendation offers a further immunotherapy option in first-line NSCLC alongside existing PD-1 and PD-L1 inhibitors already available on the NHS.

Darzalex Faspro quadruplet recommended for multiple myeloma

NICE recommended the four-drug combination of daratumumab SC, lenalidomide, bortezomib, and dexamethasone (D-VRd; Darzalex Faspro, Revlimid, Velcade) on 24 June 2026 for newly diagnosed multiple myeloma. Submitted by Janssen Biotech, this subcutaneous daratumumab-based quadruplet regimen builds on the established VRd backbone by adding the anti-CD38 monoclonal antibody daratumumab, which has consistently demonstrated improved response rates and progression-free survival in myeloma. The approval positions D-VRd as a potential new standard of care for eligible transplant-eligible and ineligible patients.

Hansizhuang recommended for extensive-stage small cell lung cancer

Serplulimab (Hansizhuang), in combination with chemotherapy and submitted by Shanghai Henlius Biotech and Fosun Pharma, received a positive recommendation on 18 June 2026 for extensive-stage small cell lung cancer (ES-SCLC). Small cell lung cancer is an aggressive malignancy with a historically poor prognosis, and first-line chemoimmunotherapy has become the standard approach following earlier immunotherapy approvals in this setting. Serplulimab is an anti-PD-1 antibody, and its recommendation provides a further immunotherapy option for patients presenting with extensive disease.

Imfinzi plus FLOT chemotherapy recommended for gastric and gastro-oesophageal junction cancer

Durvalumab (Imfinzi) in combination with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) was recommended by NICE on 3 June 2026 as a neoadjuvant and adjuvant treatment for resectable gastric cancer and gastro-oesophageal junction cancer (GEJC). Developed by AstraZeneca, the perioperative regimen adds PD-L1 blockade to an established chemotherapy backbone, reflecting evidence that immunotherapy can improve surgical outcomes and reduce the risk of recurrence in patients with potentially curable disease.

Breyanzi receives positive recommendation for diffuse large B-cell lymphoma

Lisocabtagene maraleucel (Breyanzi), a CD19-directed CAR-T cell therapy developed by Bristol Myers Squibb (via Juno Therapeutics and Celgene), received a positive second appraisal recommendation on 3 June 2026 for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). CAR-T therapies represent a complex and highly personalised treatment modality in which a patient’s own T cells are engineered to recognise and destroy cancer cells. The updated recommendation reflects revised cost-effectiveness evidence and expands NHS access to this potentially curative one-time treatment for patients who have failed two or more prior lines of therapy.

Respiratory & Cardiovascular

Nucala recommended for eosinophilic COPD

Mepolizumab (Nucala), developed by GSK, received a positive recommendation on 17 June 2026 for eosinophilic chronic obstructive pulmonary disease (COPD). Nucala is an anti-interleukin-5 monoclonal antibody already established in severe eosinophilic asthma, and this approval extends its indication to a subset of COPD patients characterised by elevated blood eosinophil counts. It represents an important development in COPD management, which has traditionally relied on bronchodilators and inhaled corticosteroids, by targeting an underlying inflammatory mechanism in eligible patients.

Winrevair recommended for pulmonary arterial hypertension

Sotatercept (Winrevair), developed by Acceleron and Merck, received a positive NICE recommendation on 3 June 2026 for pulmonary arterial hypertension (PAH). Sotatercept is an activin signalling inhibitor — a first-in-class mechanism of action in PAH — that addresses vascular remodelling, the underlying pathological process driving the progressive increase in pulmonary artery pressure that characterises this condition. Current PAH therapies largely target vasodilation; sotatercept’s distinct mechanism makes it a meaningful addition to the treatment armamentarium, particularly in combination with existing background therapy.

Nexlizet recommended for dyslipidaemia

The combination of bempedoic acid and ezetimibe (Nexlizet), submitted by Esperion Therapeutics and Daiichi Sankyo, was recommended on 24 June 2026 for dyslipidaemia in patients unable to tolerate statins or with an inadequate response to statin therapy. Bempedoic acid inhibits ATP-citrate lyase, an enzyme upstream of HMG-CoA reductase in the cholesterol biosynthesis pathway, while ezetimibe reduces intestinal cholesterol absorption. The combination provides a non-statin LDL-lowering option for a patient group that includes those with statin intolerance, an issue frequently encountered in clinical practice.

Hepatology & Gastroenterology

Livdelzi recommended for primary biliary cholangitis

Seladelpar (Livdelzi), developed by Gilead Sciences and CymaBay Therapeutics, received a positive recommendation on 24 June 2026 for primary biliary cholangitis (PBC), a rare chronic autoimmune liver disease that can lead to cirrhosis if inadequately treated. Seladelpar is a selective PPAR-delta agonist that reduces the production of bile acids and suppresses biliary inflammation. The recommendation is significant for patients who have had an inadequate response to or cannot tolerate ursodeoxycholic acid, which has long been the only licensed first-line treatment for PBC in the UK.

Neurology & Paediatrics

Spinraza recommendation updated for spinal muscular atrophy

Nusinersen (Spinraza), developed by Biogen and Ionis Pharmaceuticals, received an updated NICE recommendation on 4 June 2026 for spinal muscular atrophy (SMA). SMA is a rare and often severe inherited neuromuscular disease caused by mutations in the SMN1 gene. Spinraza was among the first disease-modifying treatments to be approved for SMA and works by modifying splicing of the SMN2 gene to increase production of functional SMN protein. The updated recommendation likely reflects revised clinical or cost-effectiveness evidence, potentially expanding eligible patient groups or amending existing access criteria.

Terminated Appraisals

Inluriyo appraisal terminated for ER-positive breast cancer

The appraisal of imlunestrant (Inluriyo), an oral selective oestrogen receptor degrader (SERD) submitted by Eli Lilly and Loxo Oncology, was terminated on 18 June 2026 for oestrogen receptor-positive, HER2-negative breast cancer with ESR1 mutation. ESR1 mutations are a recognised mechanism of resistance to aromatase inhibitors and represent a clinically important unmet need. The reasons for termination were not specified in the available data, though terminated appraisals typically reflect a withdrawal by the company or an inability to agree a managed access arrangement.

Anktiva appraisal terminated for BCG-unresponsive bladder cancer

The appraisal of nogapendekin alfa inbakicept (Anktiva), submitted by ImmunityBio and Accord Healthcare for BCG-unresponsive non-muscle-invasive bladder cancer, was terminated on 4 June 2026. BCG-unresponsive disease represents a challenging clinical situation in which patients have failed intravesical BCG immunotherapy — the standard treatment for high-risk non-muscle-invasive bladder cancer — and face a choice between radical cystectomy or further bladder-sparing treatments. The termination leaves this patient population without a new approved option via NICE at this time.

Decisions referenced carry NICE Positive 1, NICE Positive 2, NICE Update 1, or Terminated status, issued between 3–24 June 2026. This article is based on data from the NICE Technology Appraisal Programme for England and Wales.

Oncology and dermatology feature prominently in this cycle, with notable recommendations for novel antibody-drug conjugates, a new JAK inhibitor indication, and an innovative combination approach in multiple myeloma. The cycle also includes three vaccine recommendations addressing chikungunya, meningococcal disease, influenza, and orthopoxvirus infections.

Oncology

Datroway recommended for triple-negative breast cancer

Datopotamab deruxtecan (Datroway), an antibody-drug conjugate developed by Daiichi Sankyo and AstraZeneca, has received a positive CHMP recommendation for triple-negative breast cancer (TNBC). TNBC remains one of the most challenging breast cancer subtypes to treat, given its lack of hormone receptor and HER2 expression. Datroway targets TROP2, a protein overexpressed in many epithelial tumours, and delivers a cytotoxic payload selectively to cancer cells, offering a more targeted approach than conventional chemotherapy.

Tecvayli and Darzalex Faspro combination recommended for multiple myeloma

Johnson & Johnson has received a CHMP recommendation for the combination of teclistamab and daratumumab (Tecvayli and Darzalex Faspro) for multiple myeloma. Teclistamab is a bispecific T-cell engager targeting BCMA and CD3, while daratumumab is a well-established anti-CD38 monoclonal antibody. Combining the two mechanisms in a chemotherapy-free regimen represents a significant advance in the treatment of relapsed or refractory multiple myeloma, a condition that typically requires repeated lines of therapy over time.

Jaypirca recommended for chronic lymphocytic leukaemia

Pirtobrutinib (Jaypirca), a non-covalent BTK inhibitor developed by Loxo Oncology at Lilly and Eli Lilly, has been recommended for chronic lymphocytic leukaemia and small lymphocytic lymphoma (CLL/SLL). Unlike covalent BTK inhibitors such as ibrutinib, pirtobrutinib is designed to remain active in patients who have developed resistance mutations, offering a treatment option for a population with limited alternatives following prior BTK inhibitor therapy.

Denosumab biosimilar recommended for bone complications in cancer

Denosumab Ascend, a biosimilar of denosumab developed by Ascend GmbH, has received a CHMP recommendation for the prevention of skeletal-related events in patients with bone metastases and for giant cell tumour of bone. The availability of a biosimilar version of this widely used bone-targeted agent is expected to improve patient access and reduce costs for health systems across the EU.

Pegfilgrastim biosimilar recommended for neutropenia

Nylaspeg, a biosimilar of pegfilgrastim submitted by Qilu Pharmaceuticals, has received a positive recommendation for chemotherapy-induced neutropenia. Pegfilgrastim is routinely used to stimulate white blood cell production and reduce the risk of febrile neutropenia in cancer patients receiving myelosuppressive chemotherapy. The biosimilar recommendation supports continued access to this supportive care treatment at competitive cost.

Dermatology & Immunology

Rinvoq recommended for vitiligo and alopecia areata

AbbVie’s upadacitinib (Rinvoq), a selective JAK1 inhibitor, has received two separate CHMP recommendations expanding its indications into dermatology: one for vitiligo and one for alopecia areata. Vitiligo is a chronic autoimmune condition causing depigmentation of the skin, while alopecia areata results in patchy or total hair loss driven by immune-mediated attack on hair follicles. Both conditions have historically lacked effective systemic treatments, and these recommendations follow growing clinical evidence supporting JAK inhibition as a mechanism of action in autoimmune skin diseases. Rinvoq is already approved for several inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, and atopic dermatitis.

Opzelura recommended for atopic dermatitis

Ruxolitinib cream (Opzelura), developed by Incyte Corporation and Maruho, has received a CHMP recommendation for atopic dermatitis (eczema). Opzelura is a topical JAK1/JAK2 inhibitor that provides targeted anti-inflammatory activity at the site of application, offering an alternative to topical corticosteroids for patients with mild to moderate disease. The recommendation addresses a highly prevalent condition that places significant quality of life burden on patients, particularly those with disease affecting visible areas of skin.

Neurology & Paediatrics

Daybue recommended for Rett syndrome

Trofinetide (Daybue), developed by Acadia Pharmaceuticals, has received a CHMP recommendation for Rett syndrome, a rare and severe neurodevelopmental disorder caused by mutations in the MECP2 gene, which predominantly affects girls. The condition leads to progressive loss of motor and communication skills and has no approved disease-modifying treatments in the EU. Daybue is a synthetic analogue of the naturally occurring tripeptide GPE (glycine-proline-glutamate) and represents the first pharmacological treatment specifically developed for this condition to receive a positive EU recommendation.

Crexont recommended for Parkinson’s disease

A prolonged-release combination of carbidopa and levodopa (Crexont), submitted by Amneal Pharmaceuticals and Zambon, has been recommended for Parkinson’s disease. Levodopa remains the cornerstone of Parkinson’s pharmacotherapy, but standard formulations are associated with motor fluctuations and wearing-off effects as the disease progresses. The extended-release formulation aims to provide more consistent plasma drug levels throughout the day, potentially reducing the frequency and severity of motor complications in patients with advanced disease.

Stelara recommended for paediatric ulcerative colitis

Ustekinumab (Stelara), developed by Johnson & Johnson, has received a CHMP recommendation for paediatric ulcerative colitis. Ustekinumab is an interleukin-12 and interleukin-23 inhibitor already established in adult inflammatory bowel disease and psoriasis. This paediatric recommendation addresses a significant unmet need in younger patients with moderate to severe ulcerative colitis who have an inadequate response to conventional therapy.

Infectious Diseases & Vaccines

Ixchiq recommended for chikungunya fever

Ixchiq, a live-attenuated chikungunya vaccine developed by Valneva SE and Instituto Butantan, has received a positive CHMP recommendation. Chikungunya is a mosquito-borne viral illness characterised by fever and severe joint pain, with outbreaks increasingly reported in southern Europe due to the northward spread of the Aedes albopictus mosquito. The approval of a preventive vaccine represents an important public health tool as the geographical range of the disease continues to expand.

MenQuadfi recommended for meningococcal disease

MenQuadfi, a conjugate vaccine targeting meningococcal serogroups A, C, W, and Y, developed by Sanofi, has received a CHMP recommendation. Meningococcal disease can cause life-threatening bacterial meningitis and septicaemia, particularly in infants, young children, and adolescents. The conjugate formulation is designed to produce a robust and long-lasting immune response and is suitable for use in paediatric populations.

Imvanex recommended for monkeypox and orthopoxvirus infections

Bavarian Nordic’s Imvanex, a modified vaccinia Ankara-based vaccine, has received a CHMP recommendation for protection against monkeypox (mpox) and other orthopoxvirus infections. Imvanex was already authorised for smallpox prevention in the EU and was used extensively during the 2022 mpox outbreak. This recommendation formalises its indication for mpox and broader orthopoxvirus prophylaxis, reflecting the continued public health relevance of the product.

Aujemflu recommended for influenza

Aujemflu, an adjuvanted trivalent influenza vaccine developed by Seqirus/CSL, has received a CHMP recommendation for the prevention of influenza. The adjuvanted formulation is designed to enhance immunogenicity, particularly in older adults and immunocompromised populations where vaccine responses may be suboptimal. The recommendation adds to the existing portfolio of seasonal influenza vaccines available to EU member states.

Symtuza and Prezcobix recommended for HIV

Two HIV antiretroviral regimens have received CHMP recommendations. Symtuza — a single-tablet combination of darunavir, emtricitabine, cobicistat, and tenofovir alafenamide (TAF), developed by Johnson & Johnson and Gilead Sciences — offers a complete one-tablet-once-daily regimen for HIV-1 infection. Separately, Prezcobix — a combination of darunavir and cobicistat developed by Janssen Therapeutics — provides a boosted protease inhibitor backbone for use in combination with other antiretrovirals. Both recommendations likely reflect updated indications or label revisions for these established regimens.

Cardiovascular & Diabetes

Leqvio recommended for hypercholesterolaemia

Inclisiran (Leqvio), a small interfering RNA (siRNA) therapy developed by Novartis, has received a CHMP recommendation for hypercholesterolaemia. Inclisiran works by inhibiting the production of PCSK9, a protein that reduces the liver’s ability to clear LDL cholesterol from the blood. Administered just twice yearly by subcutaneous injection, inclisiran offers a highly differentiated dosing schedule compared with daily oral statins or monthly PCSK9 inhibitor antibodies, which may improve adherence in patients requiring long-term lipid-lowering therapy.

Onswik recommended for type 2 diabetes

Insulin efsitora alfa (Onswik), a once-weekly basal insulin analogue developed by Eli Lilly, has received a positive CHMP recommendation for type 2 diabetes. The treatment represents a significant step forward in insulin therapy, offering a weekly injection as an alternative to the daily or twice-daily basal insulin regimens that many patients find burdensome. A reduced injection frequency is expected to support better adherence and patient quality of life, particularly in the early stages of insulin initiation.

All nineteen decisions listed carry CHMP Recommended status. 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.

Reduced NHS spending on other health interventions would have an adverse impact on public health which could increase excess preventable deaths by 229,000 by 2036 – more than the covid-19 pandemic between March 2020 and June 2022 (137,000). If the indirect effect on adult social care is also included, excess deaths increase to 291,000, argue the authors. Most of these deaths are expected to be people with cardiovascular, respiratory, and gastrointestinal disease and cancer.

The UK-US pharmaceuticals deal was announced by the UK government on 1 December 2025 and described as a “landmark” deal that would “safeguard medicines access and drive vital investment for UK patients and businesses” through strengthening UK-US cooperation in sectors like life sciences and pharmaceuticals.

The agreement secured a 0% tariff on UK pharmaceutical and medical device exports to the US for three years, but also committed the NHS to substantially higher expenditure on new branded medicines over the next decade through changes to drug pricing arrangements and health technology assessment.

From April 2026 the government instructed the National Institute for Health and Care Excellence (NICE) to increase its cost-effectiveness threshold for new medicines from £20,000-£30,000 per quality adjusted life year (QALY) to £25,000-£35,000 per QALY for the same health benefits.

Changes in the way health benefits are measured by NICE’s assessments will also give more weight to benefits offered by new medicines. QALYs combine gains in survival and quality of life into a single measure and NICE has generally required a cost-effectiveness threshold of £20,000-£30,000 per QALY to balance the health gains offered by new medicines against the detrimental impact on health if NHS resources were displaced from other services.

An agreement between the pharmaceutical industry and the UK government (the voluntary scheme for branded medicines pricing, access, and growth; VPAG) designed to limit growth in NHS expenditure on branded medicines through industry rebate payments has also been watered down. In 2025 the rebate rate was 23% but under the new agreement this has been cut to 14.5%.

Overall, under the deal, the government has committed to more than double spending on new medicines from 0.3% of gross domestic profit (GDP) to at least 0.6% by 2036, with interim targets of 0.35% of GDP in 2028 and 0.4% of GDP in 2030.

The Department of Health and Social Care has undertaken an impact assessment on the wider costs of this trade deal, but this document has not been made publicly available.

The authors are calling for the full details of the deal and its impact assessment to be made public so the deal can receive parliamentary scrutiny. They also emphasise that many of the suggested benefits of the deal, such as claims that higher UK medicine prices will stimulate pharmaceutical innovation and investment in the UK, are uncertain.

Assuming these GDP targets are met and GDP rises by 1.5% annually, as predicted by the Office for Budgetary Responsibility (OBR), the additional annual costs to the English NHS will be at least £1.3bn in 2028 (£25m per week), and £8.8bn in 2036 (£170m per week). The cumulative additional cost will be £2.6bn by the end of 2028 and £44.7bn by the end of 2036.

Modelling of English local authority data suggests that every £1bn the NHS must find to fund this deal will increase the costs of publicly funded adult social care by £118m because of increases in morbidity and mortality.

NICE estimates that increasing cost effectiveness thresholds will result in only two to five additional medicines being approved annually. NICE already approves more than 90% of medicines it evaluates, suggesting that the agreement is more likely to increase the prices paid for medicines already entering the NHS rather than substantially expand access.

While the agreement establishes zero tariffs on UK pharmaceutical and medical device exports to the US for three years, the UK remains a net importer of medicines. The economic benefits of securing zero tariffs for UK pharmaceutical exports has also been substantially diminished since a US Supreme Court ruling reduced the proposed tariffs from 100% to 10%. The projected costs of the agreement are expected to exceed the total annual value of UK medical exports to the United States (£5bn) before 2031.

The authors say, “The government’s willingness to accommodate industry pressure while the NHS absorbs the resulting costs raises important questions about transparency and accountability.”

They add, “More importantly, it emphasises a broader structural problem at the heart of a health system conceived with the intention of delivering equitable, patient centred care, now reduced to underwriting risk in global pharmaceutical markets.”

Chile ranks among the highest countries globally for rates of childhood overweight and obesity [1]. To combat this issue, in 2016 Chile implemented one of the world’s most comprehensive and ambitious food policies, the Food Labelling and Advertising Law (FLAL) [2].

The FLAL targets foods and drinks high in sugars, saturated fats, salt, or calories through three core measures: mandatory front-of-package warning labels in the form of black octagons (images available here), restrictions on the sale of such products in schools, and limits on food marketing directed at children.

Prof Guillermo Paraje, Professor of Economics, Universidad Adolfo Ibáñez Business School (Chile), says, “Although individual national measures like sugar taxes on soft drinks have been associated with improved health outcomes, this is the first study to plausibly demonstrate that a package of policies can reduce early childhood overweight/obesity risk at the national level.

“These results offer strong evidence for policymakers around the world. They support mandatory front-of-pack nutrition warning labels, restrictions on unhealthy food in schools, and marketing bans as effective, practical ways to tackle the childhood obesity epidemic.”

National data on more than 300,000 schoolchildren aged four to six in Chile was used to compare children’s weight from the years before the introduction of FLAL with the weight and size of children in the same school grades after the first phase of the law came into place in 2016.

The study found that children who had been at school for 18 months after the introduction of FLAL Phase 1 were less likely to be overweight or have obesity than those in the same grades before FLAL. Girls had a 2.9% lower risk of overweight or obesity (a reduction of 1.4 percentage points from a pre-FLAL rate of 47.7%) while boys had a 2.4% lower risk (a reduction of 1.2 percentage points from a pre-FLAL rate of 52%.)

The study also found a plausible causal impact in the cohort of schoolchildren aged four to six after only six months of the FLAL Phase 1; girls had a 1.9% lower risk of overweight or obesity (a reduction of 0.9 percentage points from a pre-FLAL prevalence of 47.4%) and boys a 2.2% lower risk (a reduction of 1.2 percentage points from a pre-FLAL prevalence of 52%).

Phases 2 and 3 of FLAL set stricter limits on sugars, saturated fats, salt, or calories. These phases were introduced in 2018 and 2019, so they did not impact the study’s results.

Dr Nieves Valdes, Associate Professor of Economics, Universidad Adolfo Ibáñez Business School (Chile), says, “Although the reduction in obesity and overweight risk among young school children may seem modest, it is likely that the further tightening of the law in later years will have increased the impact, especially given evidence that there was a greater drop in sales of labelled food products during Phase 2 of the FLAL compared to Phase 1.”

“Additionally, even a small weight reduction for children who have overweight or obesity is likely to bring meaningful long-term health benefits, given the strong links between childhood obesity and later risk of obesity, diabetes, hypertension, and cardiovascular disease, as well as evidence that early prevention can substantially lower these risks.”

The researchers note some limitations of their studies, including that the plausible causality of the relationship relies on the assumption that, if the FLAL hadn’t been introduced, the two cohorts of school children would have followed the same nutrition trends, which cannot be tested although support for the assumption was provided through pre-policy trends. Additionally, the children’s weight was collected by school staff who, although trained for this task, may not achieve the same precision typically found in primary health care settings.

Writing in a linked Comment, Professor Simone Pettigrew and Dr Daisy Coyle, The George Institute for Global Health (Australia), who were not involved in the study, say, “In a policy environment where industry opposition constitutes a formidable obstacle to the implementation of health-promoting policies, high-quality, real-world evidence is critical. […] the research results strengthen the case for governments to move beyond incremental, single-policy approaches and to instead implement comprehensive, integrated strategies to improve food environments. In particular, the results highlight the potential for policy suites including mandatory warning labels and marketing restrictions on unhealthy foods and school food minimum standards to produce meaningful outcomes.”

• Jascayd (nerandomilast) for the treatment of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF), two serious lung diseases that involve progressive and irreversible scarring (fibrosis) of the lung tissue.
• Vijoice (alpelisib) for the treatment of patients with severe PIK3CA-related overgrowth spectrum (PROS) disorders.
• Boey (trenibotulinumtoxinE) for the temporary improvement in the appearance of moderate to severe lines between the eyebrows when these have an important psychological impact in adults.
• Etcamah (camizestrant) for the treatment of adults with locally advanced or metastatic breast cancer with a specific mutation in the ESR1 gene.
• Ablymico (liraglutide), indicated for weight management.
• Liraglutide STADA (liraglutide) for the treatment of insufficiently controlled type 2 diabetes as an adjunct to diet and exercise.
• Colchicine AGEPHA Pharma (colchicine) for the secondary prevention of atherothrombotic events in adults with coronary disease who have been stable for at least six months.
• Vislyfa (ranibizumab) for the treatment of neovascular age-related macular degeneration, visual impairment and other retinopathies.

The committee recommended extensions of indication for 13 medicines that are already authorised in the European Union (EU): Braftovi, Enhertu, Erbitux, Fasenra, Hetronifly, Iclusig, Keytruda, Maviret, Padcev, Palynziq, Sogroya, Tepkinly and Trodelvy.

The One Health social media initiative is a joint project between the EMA and several other EU bodies, including the European Food Safety Authority, European Environmental Agency and European Chemicals Agency. It’s part of a Europe-wide effort to raise awareness of the close links between human, animal and environmental health.

The One Health approach aims to prevent the emergence of health threats, and to help mitigate their impact and societal costs; reduce human pressures on the environment; and safeguard key societal needs such as food security, and access to clean air and water.

The Instagram account connects younger people with EU work on One Health. The account focuses on simplifying complex topics related to science, health, environment, and safety through visual storytelling and relatable content.

The Award for Good Administration recognises EU projects that have a meaningful and positive impact on the daily lives of European citizens and beyond. A public vote is under way, closing on 15 June, before the award ceremony on 30 June.

The initiative is part of a wider effort to support clinicians and the public in understanding the robust regulatory system that underpins vaccine safety. It shows how regulators require strong evidence to approve vaccines, but also highlights how real-world evidence is collected from millions of doses after vaccines become available to the public.

The first Vaccine Essentials publication focuses on Meningococcal group B vaccines (MenB). MenB vaccines were chosen in part because the story of how they are regulated illustrates the value of combining immunogenicity data (which shows that the vaccine induces an immune response) with real-world effectiveness studies that determine impact of a vaccine in a clinic.

‘In the case on MenB vaccines, by supplementing the initial evidence (pre-approval) with additional data (post-approval), regulators were able to further confirm the vaccines’ safety, effectiveness, as well as their favourable benefit/risk balance,’ the EMA says.

The MenB factsheet was developed with the European Academy of Paediatrics and based on a peer-reviewed publication. ‘MenB vaccines represent a success story on the prevention of a very serious disease mainly affecting infants and teenagers,’ said Dr Hans J. Dornbusch of the European Academy of Paediatrics. ‘In clinical practice, in a child with fever, if all meningococcal immunisation is up to date, the risk of severe illness including meningitis is really low.’

The Agency has also assembled a new advisory group on vaccine confidence, bringing together international experts to advise on how to build and maintain trust in the regulatory system. Rather than championing vaccines per se, the regulator seeks to ensure that important health decisions are taken based on evidence and a sound understanding of science.

The pathway aligns regulatory review by the Medicines and Healthcare products Regulatory Agency (MHRA) with the National Institute for Health and Care Excellence (NICE) health technology appraisal process, so that decisions are reached simultaneously.

But Huseyin Naci at the London School of Economics and Political Science notes that these two bodies require different forms of evidence. The MHRA focuses on a product’s clinical effectiveness and safety, while NICE assesses its comparative effectiveness and long term value for money against current NHS treatments.

Rather than aligning evidentiary standards, the pathway runs two independent processes in parallel with the aim of synchronising their conclusions, he explains, offering companies earlier revenue and a longer rebate-free window, while benefits for patients and the NHS are less clear.

He acknowledges that earlier access to effective new drugs can matter for patients with significant unmet needs, but says, unlike the patient-focused Innovative Licensing and Access Pathway (ILAP), the new pathway expedites all new medicines regardless of added therapeutic benefit.

The pathway will also impose timelines to ensure that MHRA and NICE decisions are reached simultaneously. Yet Naci points out that fixed drug evaluation deadlines have historically been linked to higher rates of adverse events, and fast-tracked medicines are more prone to post-marketing safety issues than those approved through standard routes.

A further problem is that NICE committees may be asked to assess products on evidence not yet fully vetted by the MHRA, compounding the uncertainty under which they already operate, he writes.

Earlier adoption of expensive, potentially low-value medicines will also extend the period over which they divert NHS resources from more cost-effective interventions, a problem exacerbated by the 2025 US-UK trade agreement committing NICE to a 25% higher cost-effectiveness threshold, he adds.

Naci urges the government to ground medicines access policy in patient need and population health, calling for clarification on the assumptions underpinning the pathway and assessment of its anticipated benefits and harms for all stakeholders, not just industry.

NICE’s focus on synchronisation of decisions risks overlooking whether the NHS will be adequately protected from the earlier adoption of medicines that prove harmful, ineffective, or poor value, he concludes.

The study examined the facilitators and challenges of so-called tobacco endgame policies in Europe. These policies refer to goals and measures aimed at reducing the use of tobacco products in the population to such a low level that it no longer places a significant burden on public health. Tobacco causes more than seven million premature deaths worldwide each year.

The EU’s Tobacco-Free Generation target was launched in the 2021 Cancer Plan and was recently reinforced in the Safe Hearts Plan. The aim is to reduce the use of tobacco products among the European population to below five per cent by 2040.

EU support is decisive for achieving the targets

According to the study, achieving the targets is particularly supported by broad political commitment, effective and long-term cooperation between different actors, and an active civil society that keeps the issue visible and brings public opinion to light.

In contrast, tobacco industry influence on decision-making, the visible marketing of new nicotine products, and the slowness of regulation make progress towards the targets more difficult.

The interviewees saw the EU’s role as central in reducing the use of tobacco and nicotine products. Common EU regulation and examples from other countries can accelerate national measures and encourage countries to set more ambitious targets for reducing the use of tobacco and nicotine products.

“The ongoing revision of EU tobacco legislation provides an important opportunity to strengthen Member States’ actions and accelerate progress towards the Tobacco-Free Generation target,” says Senior Specialist Hanna Ollila from the Finnish Institute for Health and Welfare.

Finland has been a forerunner

In some countries, the target has been extended to cover nicotine products as well. Finland has been a forerunner in this respect. In Finland, the objective of the Tobacco Act is to end the use of tobacco and nicotine products. In practice, the aim is to achieve a prevalence below five per cent by 2030.

“It is important for Finland to continue its active role and ensure that national regulation remains up to date, particularly with regard to new nicotine products. The rapid increase in the use of nicotine pouches among young people requires swift additional measures, such as raising the age limit,” Ollila states.

The study is based on interviews with 23 experts in eight European countries. The interviewees included officials, researchers and representatives of non-governmental organisations. It was carried out as part of the Joint Action on Tobacco Control 2 -project, within a work package led by THL.

The warning label currently required on alcohol containers in the United States has not changed since its adoption in 1988, despite new evidence linking alcohol to several diseases. The label states the risks of drinking during pregnancy and while driving or operating machinery and warns generally that drinking alcohol “may cause health problems.” The label often goes unnoticed and unremembered by consumers.

“We wanted to test whether new warnings could better inform consumers about alcohol’s harms and better encourage people to consider cutting back on their drinking,” says lead author Anna H. Grummon, Ph.D., M.S.P.H., assistant professor at the Stanford University School of Medicine. The study was conducted as part of a larger project co-led with Marissa G. Hall, Ph.D., associate professor at the University of North Carolina.

Designed to compare the effects of differently worded and designed warning labels, the study recruited a nationally representative sample of 1,036 adults of legal drinking age (21 and older) who reported drinking at least once a week.

Participants viewed 10 messages — one control, eight new warning labels, and the current U.S. warning label — in random order. They then rated each message on how well it encouraged them to drink less alcohol, reminded them of alcohol’s harms, and informed them of something new.

“Each participant rated multiple warnings covering a range of health harms — such as cancer, liver disease, hypertension, and dementia, among others — so we could make direct, apples-to-apples comparisons between them,” says Grummon.

All the new alcohol warnings in the study outperformed the current U.S. warning label, but those highlighting cancer risk were particularly effective. This finding is notable as policymakers in the United States and abroad debate whether to adopt a cancer warning on alcohol products.

“Ireland, for example, is set to require cancer warnings on alcohol containers in the coming years, and Alaska already requires a cancer warning to be posted in bars, restaurants, and liquor stores where alcohol is sold,” says Grummon. “Our findings suggest these policies could help people understand the risks of drinking and potentially reduce consumption.”

Study participants also rated the effectiveness of warning icons and label design. Triangles and octagons were perceived as more effective and attention-grabbing than other icons, such as a magnifying glass.

More research is underway. Grummon and Hall are currently running a randomized trial to test whether new alcohol warnings effectively lead people to drink less. The study will also measure whether the warnings improve knowledge of alcohol-related harms over time.

“We know from tobacco control that well-designed warnings can inform consumers and encourage healthier choices,” says Grummon. “Given that alcohol-related deaths are increasing, we hope policymakers will consider whether updating alcohol warnings should be part of a broader strategy to address alcohol-related harms.”
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Grummon, A. H., Lee, C. J. Y., Campos, A. D., Lazard, A. J., Brewer, N. T., Whitesell, C., Ruggles, P. R., Greenfield, T. K., & Hall, M. G. (2026). New alcohol warnings outperform the current U.S. warning in a national survey experiment. Journal of Studies on Alcohol and Drugs, 87(3), 433-443. https://doi.org/10.15288/jsad.25-00226

By W.B. Kagan

image: “Government warning” alcohol label

View more Credit: Journal of Studies on Alcohol and Drugs

The purchasing and consumption of foods high in energy, saturated fat, free sugars, and salt, is associated with an increased risk of obesity and diet-related non-communicable diseases. In recent years, the UK Government has set a series of voluntary targets for manufacturers, retailers, and restaurants to reduce the sugar, salt, and calorie content of food. The sugar targets were intended to be met by 2020, the salt targets by 2024, and the calorie targets by 2025. Few studies have assessed the nutritional quality of foods in the restaurant sector, despite an increasing percentage of weekly food intake coming from takeaway or restaurant meals.

In the new study, researchers gathered nutritional information from the 21 highest-grossing restaurant chains in the UK in 2024, using PDF menus or nutritional information on restaurant websites. They calculated the proportion of menu items from each restaurant and food subcategory that met the nutritional targets. Nine of the 21 restaurants had more than half of their menu items meeting all applicable targets. Menu items from Papa John’s were the lowest adhering to the calorie (35%) and salt (8%) targets, while menu items from Burger King, KFC, Nando’s, and Vintage Inns had zero adherence to the sugar targets.

Food within the same subcategory varied in adherence to the targets, with salads and breakfast items having the highest overall adherence, and desserts and pizzas the lowest. However, there were examples of companies across all subcategories performing well, indicating that performance is not constrained by the type of cuisine being offered.

“Our findings demonstrate that there was low adherence to the UK Government’s sugar, salt, and calorie reduction targets in 2024,” the authors say. “This is consistent with other research that finds limited effectiveness of voluntary regulation on reformulation, suggesting that mandatory regulation may be a more effective approach to improving the nutritional quality of out-of-home food.”

Alice O’Hagan adds, “Our study shows that the UK Government’s voluntary sugar, salt, and calorie reduction targets were not being met consistently across the highest-grossing UK restaurant chains, in 2024. Only 43% of menu items met all of the targets they were eligible for, and adherence to the targets varied widely between restaurants and food categories, showing that healthier menus are achievable but are not yet the norm.”

“Interestingly, restaurants with similar menu styles performed quite differently in meeting the targets. This shows the nutritional quality of menus is not fixed by cuisine type, making the shift towards healthier menus a more attainable goal for food companies.”

Co-author Lauren Bandy adds, “Voluntary targets alone are not delivering consistent improvements in the salt, sugar or calorie content of food items on offer in UK restaurants. Our findings highlight the potential value of stricter regulation in the out-of-home sector, and show that improving transparency and accountability of individual food companies will be key in supporting healthier food provision for the UK population.”

Freely available paper in PLOS Medicine: https://plos.io/4bNeHl9

Citation: O’Hagan A, Pechey R, Forde H, Bandy L (2026) Adherence to voluntary UK sugar, salt, and calorie reduction targets in the highest-grossing restaurant chains: A cross-sectional study. PLoS Med 23(5): e1004681. https://doi.org/10.1371/journal.pmed.1004681

Author countries: United Kingdom

Funding: AOH and RP are supported by the NIHR Oxford Health Biomedical Research Centre (https://oxfordhealthbrc.nihr.ac.uk/). RP is also supported by the Royal Society and Wellcome Trust (Sir Henry Dale fellowship; 222566/Z/21/Z; https://www.royalsociety.org/grants/henry-dale/). HF is funded by the SHIFT: Sustainable and Healthy Interventions for Food Transitions project, which is funded by the Wellcome Trust (grant reference 227132/Z/23/Z; https://wellcome.org/research-funding/funding-portfolio/funded-grants/shift-sustainable-and-healthy-interventions-food), and by the COPPER project, which is funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (grant reference NIHR133887; https://fundingawards.nihr.ac.uk/award/NIHR133887). LB is supported by the NIHR Applied Research Collaboration (ARC) Oxford and Thames Valley (https://www.arc-oxtv.nihr.ac.uk/). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Image: Dan Gold, Unsplash (CC0, https://creativecommons.org/publicdomain/zero/1.0/)