Healthcare news
Breaking news, regulatory updates, FDA / EMA / WHO / national health ministry announcements.
- EMA
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 19-21 May 2026
CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion for a marketing authorisation for Nobivac NXT HC, for the active immunisation of …
- EMA
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2026
Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its May 2026 meeting.Jascayd (nerandomilast)…, CHMP statistics Key figures from the May 2026 CHMP meeting are represented in the graphic below. , CHMP statistics:…, Positive recommendations on new medicines, Boey INN trenibotulinumtoxinE Marketing authorisation applicant AbbVie Deutschland GmbH Co Therapeutic indication Temporary improvement in the…, Etcamah INN camizestrant Marketing authorisation applicant Astra Zeneca Therapeutic indication Etcamah in combination with a CDK4/6 inhibitor (palbociclib,…, Jascayd INN nerandomilast Marketing authorisation applicant Boehringer Ingelheim International GmbH Therapeutic indication Treatment of adult…, Vijoice INN alpelisib Marketing authorisation applicant Novartis Europharm Limited Therapeutic indication Vijoice is indicated for the treatment of…, Positive recommendations on new hybrid medicines, Ablymico INN liraglutide Marketing authorisation applicant STADA Arzneimittel AG Therapeutic indication Treatment of diabetes and weight…, Liraglutide STADA INN liraglutide Marketing authorisation applicant STADA Arzneimittel AG Therapeutic indication Treatment of adults, adolescents…, Colchicine AGEPHA Pharma INN colchicine Marketing authorisation applicant Agepha Pharma s.r.o. Therapeutic indication Indicated to reduce the risk of…, Positive recommendations on new biosimilar medicine, Vislyfa INN ranibizumab Marketing authorisation applicant Lupin Europe GmbH Therapeutic indication The treatment of neovascular (wet) age-related…, Negative recommendations on new medicines, Deqtynet INN copper (64Cu) oxodotreotide Marketing authorisation applicant Cis Bio International Therapeutic indication For positron emission…, Positive recommendations on extensions of therapeutic indications , Braftovi INN encorafenib Marketing authorisation holder Pierre Fabre Medicament More information Braftovi : pending EC decision, Enhertu INN trastuzumab deruxtecan Marketing authorisation holder Daiichi Sankyo Europe GmbH More information Enhertu: pending EC decision (EMA/VR/…, Erbitux INN cetuximab Marketing authorisation holder Merck Europe B.V. More information Erbitux: pending EC decision (EMA/VR/0000326978)Erbitux:…, Fasenra INN benralizumab Marketing authorisation holder AstraZeneca AB More information Fasenra: pending EC decision, Hetronifly INN serplulimab Marketing authorisation holder Accord Healthcare S.L.U. More information Hetronifly: pending EC decision, Iclusig INN ponatinib Marketing authorisation holder Incyte Biosciences Distribution B.V. More information Iclusig: pending EC decision, Keytruda INN pembrolizumab Marketing authorisation holder Merck Sharp Dohme B.V. More information Keytruda: pending EC decision (EMA/VR/…, Maviret INN glecaprevir / pibrentasvir Marketing authorisation holder AbbVie Deutschland GmbH Co. KG More information Maivret : pending EC…, Padcev INN enfortumab vedotin Marketing authorisation holder Astellas Pharma Europe B.V. More information Padcev : pending EC decision, Palynziq INN pegvaliase Marketing authorisation holder BioMarin International Limited More information Palynziq : pending EC decision, Sogroya INN somapacitan Marketing authorisation holder Novo Nordisk A/S More information Sogroya : pending EC decision, Tepkinly INN epcoritamab Marketing authorisation holder AbbVie Deutschland GmbH Co. KG More information Tepkinly : pending EC decision, Trodelvy INN sacituzumab govitecan Marketing authorisation holder Gilead Sciences Ireland Unlimited Company More information Trodelvy : pending EC…, Withdrawal of initial marketing authorisation applications, Veblocema INN infliximab Marketing authorisation holder Celltrion Healthcare Hungary Kft. More information Veblocema : questions and answers, Orblid INN bevacizumab Marketing authorisation holder Laboratoires Delbert More information Orblid : questions and answers, Other updates, Wegovy INN semaglutide Marketing authorisation holder Novo Nordisk A/S More information Wegovy : pending EC decision (EMA/X/0000296344) News…, Overview of (invented) names reviewed in April 2026 by the Name Review Group (NRG) adopted at the…
- EMA
New medicine for two types of pulmonary fibrosis
EMA has recommended granting a marketing authorisation in the European Union (EU) for Jascayd (nerandomilast) to treat adults with idiopathic pulmonary fibrosis (IPF) or…
- EMA
EMA closed on Whit Monday, 25 May
EMA’s office is closed on 25 May, to mark Whit Monday. The office reopens 08:30 on Tuesday, 26 May.The product emergency hotline is available outside working hours and on…
- EMA
EU tracks progress towards 2030 clinical trial targets
The European Commission (EC), the Heads of Medicines Agencies (HMA) and EMA have published their first report tracking progress against the EU’s new clinical trial targets.…
- EMA
EMA actively monitoring cruise ship Hantavirus outbreak
EMA is actively monitoring the ongoing hantavirus outbreak linked to a cruise ship, in coordination with other EU bodies.The virus has been identified as Andes hantavirus, the…
- EMA
EMA business hours over Ascension Day holidays, 14 and 15 May
EMA's office is closed from 18:00 on 13 May 2026 until 08:30 on 18 May 2026.The product emergency hotline is available outside working hours and on public holidays. To reach…
- EMA
EMA welcomes political agreement on Critical Medicines Act
EMA welcomes the provisional agreement reached by the European Parliament and the Council of the European Union on the proposed Critical Medicines Act (CMA), which represents an…, “At a time of increasing global disruptions, resilient and secure supply chains for critical medicines are essential to protect public health across the EU. Today’s…, In recent years, EU Member States have faced serious medicine shortages and global challenges such as the COVID-19 pandemic and geopolitical tensions have exposed…
- EMA
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 May 2026
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines:…, Agenda Agenda of the PRAC meeting 4-7 May 2026Draft Reference Number…, PRAC statistics: May 2026 , PRAC statistics: May 2026 English (EN) (104.16 KB - PDF)First published:…, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between…
- EMA
EU recommendations for 2026/2027 seasonal flu vaccine composition
This news announcement was updated on 7 May 2026 to include additional recommendations for strains for seasonal egg-derived and live-attenuated influenza vaccinesEMA has issued…
- EMA
EMA launches new advisory group on vaccine confidence
EMA has set up a new advisory group on vaccine confidence, which will advise the Agency on issues related to vaccine hesitancy and help guide its actions to increase science…, "Vaccine hesitancy is a growing global threat to public health. When public trust declines, infectious diseases can reemerge, putting lives at risk. EMA has a vital…, The advisory group on vaccine confidence will meet quarterly. It includes academics, representatives of healthcare professionals, medical societies and patient organisations, as…
- EMA
New pilot to support development of ‘breakthrough’ medical devices
EMA has launched a pilot programme to support the development of breakthrough medical devices in the European Union (EU). The purpose of the pilot is to test a new regulatory…
- EMA
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2026
Update as of 18 May 2026'CHMP statistics' graphic - updated figures for total negative opinions on new medicines and for positive opinions on extensions of therapeutic…, CHMP statistics Key figures from the April 2026 CHMP meeting are represented in the graphic below. , CHMP statistics:…, Positive recommendations on new medicines, Cenrifki INN tolebrutinib Marketing authorisation applicant Sanofi Winthrop Industrie Therapeutic indication Treatment of non-relapsing secondary progressive…, Itvisma INN onasemnogene abeparvovec Marketing authorisation applicant Novartis Europharm Limited Therapeutic indication Treatment of 5q spinal muscular…, Redemplo INN plozasiran Marketing authorisation applicant Arrowhead Pharmaceuticals Ireland Limited Therapeutic indication Treatment of familial…, Positive recommendations on new biosimilar medicine, Rexatilux INN ranibizumab Marketing authorisation holder Intas Third Party Sales 2005 S.L. Therapeutic indication Treatment of adults with neovascular (wet)…, Positive recommendations on new generic medicine, Palbociclib Viatris INN palbociclib Marketing authorisation holder Viatris Limited Therapeutic indication Treatment of breast cancer More information…, Positive recommendations on extensions of therapeutic indications , Agamree INN vamorolone Marketing authorisation holder Santhera Pharmaceuticals (Deutschland) GmbH More information Agamree: pending EC decision, Aquipta INN atogepant Marketing authorisation holder Abbvie Deutschland GmbH Co. KG More information Aquipta: pending EC decision, Comirnaty INN COVID-19 mRNA vaccine Marketing authorisation holder BioNTech Manufacturing GmbH More information Comirnaty: pending EC decision, Crysvita INN burosumab Marketing authorisation holder Kyowa Kirin Holdings B.V. More information Crysvita: pending EC decision, Inaqovi INN decitabine / cedazuridine Marketing authorisation holder Otsuka Pharmaceutical Netherlands B.V. More information Inaqovi: pending EC decision, Opdivo INN nivolumab Marketing authorisation holder Bristol-Myers Squibb Pharma EEIG More information Opdivo: pending EC decision, Privigen INN human normal immunoglobulin Marketing authorisation holder CSL Behring GmbH More information Privigen: pending EC decision, Skyrizi INN risankizumab Marketing authorisation holder Abbvie Deutschland GmbH Co. KG More information Skyrizi: pending EC decision, Venclyxto INN venetoclax Marketing authorisation holder Abbvie Deutschland GmbH Co. KG More information Venclyxto: pending EC decision (EMA/VR/…, Withdrawal of initial marketing authorisation application, Viokat INN diazoxide choline Marketing authorisation applicant Soleno Therapeutics Europe Limited Therapeutic indication Treatment of adult and paediatric…, Withdrawal of application to change the marketing authorisation, Pluvicto INN lutetium (177Lu) vipivotide tetraxetan Marketing authorisation holder Novartis Europharm Limited More information Pluvicto: questions and answers…, Other updates Questions and answers on the outcome of assessment on use of Opdualag…
- EMA
New medicine to reduce triglycerides in adults with familial chylomicronaemia syndrome
EMA has recommended granting a marketing authorisation in the European Union (EU) for Redemplo (plozasiran) to treat adults with familial chylomicronaemia syndrome (FCS).FCS is…