• 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.

Hip dysplasia is the most common cause of hip arthritis for people under 50, according to the International Hip Dysplasia Institute. It occurs when a hip socket is too shallow to support the ball of the thigh bone. In young children, this can cause problems ranging from a mildly wiggly hip to complete dislocation. In adults, it can affect how people walk, lead to early-onset arthritis, and cause pain and mobility issues.

Late diagnosis of DDH remains a public health issue worldwide, leading to problems for adults later in life. More comprehensive ultrasound screening of infants during community-based public health services could help catch these missed cases without requiring hospital resources to conduct the initial screening, researchers said.

The methods used to screen newborns for DDH vary around the world. Most countries, including North America, South Korea, Taiwan and Japan, have a selective screening programme based first on a physical exam or family history. Only a small number of countries, including Austria, Switzerland and Mongolia, provide ultrasound screening for all newborns, which is more accurate.

Associate Professor Kyoko Yoshioka-Maeda from the Graduate School of Medicine at the University of Tokyo wanted to explore ways to catch these missed cases earlier. It was also vital to limit the burden on Japan’s medical system which has a declining number of paediatric orthopaedic surgeons.

‘I wanted to find out if these [ultrasound] devices could be successfully used in a community setting to screen infants for DDH as part of the maternal child and health programme,’ Yoshioka-Maeda explained. ‘Based on our nationwide survey, approximately 2% of municipalities use ultrasound screening because of workforce constraints. There is also a disparity between the availability of paediatric orthopaedic surgeons and hospitals in rural areas compared to urban areas.’

In Japan, about a month or two after a mother has given birth, she is visited by a public health nurse or midwife to check her recovery and the baby’s development. Public health nurses can offer guidance and community-based preventative care but differ from midwives and registered nurses in hospitals, and do not commonly use ultrasound.

Public health nurses and midwives from two rural municipalities in the island prefecture of Okinawa in southern Japan, and one in central Japan’s Aichi Prefecture participated in the study. Participants completed an e-learning module and hands-on seminar for the portable ultrasound device and the Graf method (used to diagnose DDH).

Ultrasound images were remotely reviewed by paediatric orthopaedic surgeons or an experienced senior surgeon. In total, 349 infants were screened out of a target 365, giving an overall coverage of 95.6%. Of these community-based examinations, 85.8% of the images were successfully classified by the surgeons.

Based on the ultrasound findings and other risk factors, 42 infants were referred, and of these, 41 attended hospital visits. Overall, 23 infants (54.8%) required follow-up and 2 (4.8%) treatment. However, only 6 of the 42 children (14.3%) would have previously met the criteria for a referral without ultrasound screening, demonstrating its effectiveness to support early detection of DDH.

‘We received strong support from caregivers, municipal administrators, hospitals, public health centres and paediatric orthopaedic surgeons, which was key for the success of this study,’ said Yoshioka-Maeda. ‘In order to roll this out across Japan, the first hurdle is the budget to purchase the equipment and train and support the staff. The other bottleneck is image interpretation, as there is a very limited number of paediatric orthopaedic surgeons in Japan. Developing an AI-based system could help us with that.’

Catching influenza increases the short-term risk of cardiovascular conditions, and existing evidence has shown that the vaccine reduces the risk of heart attack and stroke by preventing flu infection in the first place. The new study, which included 1,221 adults aged 40 or older in Denmark, looked at whether cardiovascular risk was reduced even if people were infected with flu despite being vaccinated.

‘If confirmed by additional studies in other settings, this would strengthen the case for prioritising influenza vaccination among people at risk of heart disease or stroke and would support refining recommendations across Europe,’ says Dr Roberto Croci, Statens Serum Institut in Copenhagen.

The study used Danish health registry data from 2014 to 2025 and included individuals aged 40 and above with a first-ever hospital admission for a heart attack or stroke within a year after an influenza virus infection. It included all lab-confirmed flu virus infections that occurred during nine consecutive influenza seasons.

The study population comprised 660 males and 561 females aged 40 years and above, with a median age of 75. Most patients were hospitalised with a stroke (65%), while 35% had a heart attack.

The risk of a first-time hospitalisation for heart attack and stroke during the first week after testing positive for influenza was found to be significantly higher than for any other period before or after; it increased threefold for a stroke and fivefold for a heart attack. This increased risk was reduced by half for people who were infected but had been vaccinated against influenza for that influenza season.

The study did not account for differences in effectiveness between influenza vaccines, which can vary depending on how well the vaccine formulation matches the viral strains circulating in that season. It could also not assess whether vaccination timing or gender affected outcomes.

However, the results add to the growing importance of protecting against infectious diseases in people at risk of cardiovascular events. ‘Highlighting the dual protection offered by vaccination, against both infection and its cardiovascular complications, could have a substantial public health impact,’ the authors said.

Factoring the vaccine’s added protection against these conditions into economic and burden analysis could also help make a stronger economic case for influenza vaccination programmes.

Diabetes and obesity have long been linked to an increased risk of mental health symptoms. Similarly, individuals with mental disorders have an elevated risk of metabolic diseases such as obesity and diabetes. Researchers have working to disentangle the connections between these conditions.

Previous evidence on the effects of GLP-1 medications on anxiety and depressive disorders has been somewhat inconsistent, but it has been largely based on small studies. The new paper, published in The Lancet Psychiatry, includes data from nearly 100,000 participants, over 20,000 of whom had used GLP-1 medications to treat diabetes and obesity. Participants were followed through Swedish national registers between 2009 and 2022.

The results showed that the use of GLP-1 medications – particularly semaglutide – was associated with a reduction in workplace absence and in lower rates of hospital care for psychiatric issues. During periods of semaglutide use, the reduction was 42% compared with periods when GLP-1 medications were not used. For depression, the risk was 44% lower, and for anxiety disorders, 38% lower.

In addition, semaglutide use was associated with a lower risk of substance use disorders: hospital care and sickness absence related to substance use were 47% lower during periods of semaglutide use compared with periods without GLP-1 medication. The use of GLP-1 receptor agonists was also associated with a reduced risk of suicidal behaviour.

One of the study’s authors, Professor Mark Taylor from Griffith University, says such results were to be expected: ‘An earlier study examining Swedish registers found the use of GLP-1 medications to be associated with a reduced risk of alcohol use disorder. Alcohol-related problems often have downstream effects on mood and anxiety, so we expected the effect to be positive on these as well.’

However, the magnitude of the association surprised the researchers. ‘Because this is a registry-based study, we cannot determine exactly why or how these medications affect mood symptoms, but the association was quite strong,’ says Prof Markku Lähteenvuo from the University of Eastern Finland. ‘It is possible that, in addition to factors such as reduced alcohol consumption, weight loss-related improvements in body image, or relief associated with better glycaemic control in diabetes, there may also be direct neurobiological mechanisms involved – for example, through changes in the functioning of the brain’s reward system.’

Every year, EMA issues EU recommendations for the composition of seasonal influenza vaccines on the basis of observations by the World Health Organization (WHO), which are informed by regular monitoring activities on the prevalence and characteristics of different influenza viruses worldwide.

Manufacturers of live-attenuated vaccines or egg-based vaccines should include these three virus strains for the 2026/2027 season:

• an A/Missouri/11/2025 (H1N1)pdm09-like virus;
• an A/Darwin/1454/2025 (H3N2)-like virus;
• a B/Tokyo/EIS13-175/2025 (B/Victoria lineage)-like virus.

Manufacturers of cell-based vaccines should include these three virus strains for the 2026/2027 season:

• an A/Missouri/11/2025 (H1N1)pdm09-like virus;
• an A/Darwin/1415/2025 (H3N2)-like virus;
• a B/Pennsylvania/14/2025 (B/Victoria lineage)-like virus.

Previously, most authorised influenza vaccines were formulated to protect against the four main strains of influenza responsible for seasonal flu, including the strain known as B/Yamagata.

However, since B/Yamagata has not been detected in circulation since March 2020, it is considered to no longer pose a threat to public health. As a result, there is no EU recommendation for a B/Yamagata strain in seasonal influenza vaccines for the 2026/2027 influenza season, which is in line with the respective WHO recommendation regarding the composition of vaccines for 2026/2027.
In case quadrivalent vaccines are still required (e.g. in regions where the transition to trivalent vaccines has not been finalised yet), vaccine manufacturers of inactivated vaccines can consider producing a quadrivalent vaccine containing two influenza B virus strains for the 2026/2027 season. For these vaccines it is proposed to follow WHO recommendations from previous years for the B/Yamagata strain, i.e. a B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.

Influenza viruses continuously change and evolve. The periodic replacement of the virus strains contained in influenza vaccines is therefore necessary to keep the vaccines effective.

The newly approved medicines are:

• Adstiladrin (nadofaragene firadenovec), for the treatment of adult patients with Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumours.
• Imdylltra (tarlatamab), a new treatment for relapsed extensive-stage small cell lung cancer which addresses an unmet medical need in adults with poor prognosis and limited treatment options.
• Joenja (leniolisib) for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older and weighing 45 kg or more. APDS is a rare, inherited progressive and potentially life-threatening condition of the immune system.
• Zepzelca (lurbinectedin) for the maintenance treatment in patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy.
• Bopediat (furosemide) for the treatment of oedema (swelling caused by excess fluid) of cardiac or renal origin, oedema of hepatic origin and hypertension in children from birth to under 18 years of age with chronic kidney disease.

The committee also recommended extensions of indication for 13 medicines that are already authorised in the EU: Besponsa, Capvaxive, Feraccru, Hetronifly, Hympavzi, Imcivree, Lojuxta, Mekinist, mResvia, Namuscla, Retsevmo, Sotyktu and Tafinlar.

Newly-approved products

• Fylrevy (estetrol), a hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women who have had a hysterectomy. This medicine is indicated to alleviate symptoms such as a hot face, neck and chest, also known as ‘hot flushes’.
• Ilumira (lutetium (177Lu) chloride), a radiopharmaceutical precursor, for the radiolabelling of carrier medicines that have been specifically developed and authorised for radiolabelling with lutetium chloride.
• Kayshild (semaglutide), a GLP1 receptor agonist for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis, a serious disease where fat deposits accumulate in the liver causing inflammation.
• Kygevvi (doxecitine / doxribtimine), the first treatment for thymidine kinase 2 deficiency, a rare, life-threatening genetic disease that affects fewer than one in a million people and for which there was no authorised treatment.
• Supemtek (trivalent influenza vaccine (recombinant, prepared in cell culture)), a vaccine for the prevention of influenza in adults and children from nine years of age.
• Rezurock (belumosudil), a medicine intended for the treatment of chronic graft-versus-host disease, a condition in which donor cells of a bone marrow or stem cell transplant attack the host body. The committee concluded that this medicine is to be used when other treatment options provide limited clinical benefit, are not suitable or have been exhausted.

The committee recommended extending the use of Zynyz (retifanlimab) for the treatment of adults with squamous cell carcinoma of the anal canal (SCAC) that cannot be removed by surgery and is metastatic or locally recurrent. The CHMP also adopted a positive opinion on Eurneffy (epinephrine) with a new strength (1 mg nasal spray, solution) indicated for children with a body weight of 15 kg to less than 30 kg. Eurneffy is the first emergency treatment against allergic reactions that is administered as a nasal spray, not as an injection.

Finally, the committee recommended another seven extensions of indication for medicines that are already authorised in the EU: Akeega, Efmody, Iclusig, Imfinzi, Kerendia, Noxafil and Opdivo.

There is no new evidence that would require changes to the current long-standing recommendation, the Agency stressed. It cited a recent systematic review and meta-analysis published in The Lancet Obstetrics, Gynaecology & Women’s Health which found no evidence linking paracetamol to autism, ADHD or intellectual disability in children.

‘Paracetamol remains an important option to treat pain or fever in pregnant women,’ said EMA’s Chief Medical Officer, Steffen Thirstrup. ‘Our advice is based on rigorous assessment of the available scientific data and we have found no evidence that taking paracetamol during pregnancy causes autism in children.’

The unusual decision to issue a statement – which announces no change in advice and no new evidence to review – comes in response to misinformation which falsely linked the common pain reliever with developmental changes. This idea was repeated by senior politicians in the United States in recent months, sparking widespread concern worldwide.

Without naming those who have perpetuated the myth, the EU regulator pushed back against the baseless medical claim which has potential to cause distress and avoidable physical suffering for pregnant women with a fever.

The EMA said it has a large amount of data from pregnant women who used paracetamol during pregnancy, over a very long period of time, and has seen no evidence of any risk of malformations in the developing foetus or in newborns.

‘When needed, paracetamol can be used during pregnancy. As with any medicine for acute treatment, it should be used at the lowest effective dose, for the shortest possible time and as infrequently as possible,’ the EMA statement said. ‘Pregnant women should speak to their healthcare professional if they have questions about any medication during pregnancy.’

Amid growing adoption of new AI tools across the industry, the regulators have set out broad guidance on how the technology can be used to generate evidence, manufacture products and monitor safety.

The principles are relevant for those developing medicines, as well as for marketing authorisation applicants and holders, the regulators said in a joint statement. They will underpin future AI guidance in both jurisdictions and support enhanced international collaboration. The development of formal guidelines in the EU is already underway, building on the EMA AI reflection paper published in 2024.

‘The principles are a good showcase of how we can work together on the two sides of the Atlantic to preserve our reading role in the global innovation race, while ensuring the highest level of patient safety,’ said European Commission for Health and Animal Welfare, Olivér Várhelyi.

The European Commission’s Biotech Act proposal, published in December, notes the promise of AI as a tool to accelerate innovation. New pharmaceutical legislation, meanwhile, aims to accommodate the broader use of AI in regulatory decision-making, and creates additional possibilities for testing AI-driven methods for medicines in a controlled environment.

To realise these benefits, say regulators, AI needs to be expertly managed, including the mitigation of risks. Ethics should be at the forefront of policymaking and regulations, it noted.

As AI continues to evolve, a principles-based approach will help regulators, pharmaceutical companies and medicines developers harness the potential of these technologies while ensuring patient safety and regulatory compliance.

The work which was led by Anick Bérard, a Canadian researcher, points to methodological inadequacies in previous reviews and studies. It offers reassurance for pregnant women, public health agencies, and healthcare providers in alignment with recommendations from the Centers for Disease Control and Prevention (CDC), American College of Obstetricians and Gynecologists (ACOG), and The Society of Obstetricians and Gynecologists of Canada (SOGC).

Paracetamol/acetaminophen is the most commonly used over-the-counter pain reliever during pregnancy, taken in an estimated 70% of all pregnancies. In 2021, a commentary about a possible increased risk of NDDs in children exposed to acetaminophen in utero was published, leading to substantial concerns in the general population and among prescribers. However, this publication—as well as a subsequent narrative review by the same group of researchers—was met with criticism of its methodology, choice and quality of studies considered, and lack of mechanistic data.

Acetaminophen exposure during pregnancy is difficult to assess in epidemiological studies because it is available over the counter without a prescription and is used as needed. Hence, there is inconsistency between studies regarding the risk of NDDs associated with its use in pregnancy.

‘Given the significant methodological challenges in this area, additional individual studies will inevitably suffer the same limitations as are already present in published studies,’ explains Dr Bérard of the University of Montreal and CHU Sainte-Justine, Montréal, Quebec, Canada. ‘An integrative approach, summarising the present state of knowledge and quantifying specific methodological areas of biases, as our study does, is needed in order to have a significant impact in future studies performed as well as on the causal effect of acetaminophen use during pregnancy on the risk of specific NDDs.’

Dr Bérard and an international group of experts in the field conducted a comprehensive search of major bibliographic databases and grey literature to identify human studies evaluating the association between prenatal acetaminophen exposure and the risk of NDDs in offspring. Sixteen studies retrieved met eligibility criteria.

The authors conclude that the observed increase in risk is likely not causal and can be explained by inherent biases and underlying genetic factors. They recommend further studies to examine this association more robustly.

Commenting on the study, noted expert in the field Dr David Coghill, University of Melbourne, said it was a landmark piece of work that highlights the importance of good science and strong methods. ‘The findings of no association between acetaminophen [paracetamol] use during pregnancy and the risk of autism and ADHD in the child are not unexpected. These new findings support the position of professional organisations and regulatory bodies around the world that women should continue to use acetaminophen during pregnancy and do so without fear. The fact that they contradict the recent announcements by the US government must be acknowledged and acted on.’