12 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its September 2026 meeting.The committee recommended…, CHMP statistics Key figures from the September 2026 CHMP meeting are represented in the graphic below. © European Medicines Agency, CHMP statistics:…, Positive recommendations on new medicines, Frehemgo International non-proprietary name (INN) denecimig Marketing authorisation applicant Novo Nordisk A/S Therapeutic indication Treatment of prophylaxis…, Gevalka INN ensartinib Marketing authorisation applicant SFL Pharmaceuticals Deutschland GmbH Therapeutic indication The treatment of adult patients with…, Klygefa INN gefurulimab Marketing authorisation applicant Alexion Europe Therapeutic indication Treatment of adult patients with generalised myasthenia gravis…, Lifyorli INN relacorilant Marketing authorisation applicant Corcept Therapeutics Netherlands B.V Therapeutic indication Lifyorli in combination with nab-…, Povofortay INN povorcitinib Marketing authorisation applicant Incyte Biosciences Distribution B.V Therapeutic indication Treatment of active moderate to…, Sepalna INN senaparib Marketing authorisation applicant SFL Pharmaceuticals Deutschland GmbH Therapeutic indication Maintenance treatment of advanced…, VaxRabeo INN Rabies vaccine (inactivated) for human use Marketing authorisation applicant Sanofi Winthrop Industrie Therapeutic indication Pre-exposure and…, Zeydovio INN glepaglutide Therapeutic indication Treatment of adults with Short Bowel Syndrome More information Zeydovio : pending EC decision, Positive recommendation on new biosimilar medicine, Adcomfo INN omalizumab Marketing authorisation applicant Advanz Pharma Limited Therapeutic indication Treatment of asthma, chronic rhinosinusitis with nasal…, Pebrilzo INN pertuzumab Marketing authorisation applicant Biosimilar Collaborations Ireland Limited Therapeutic indication Treatment of breast cancer in…, Positive recommendations on new generic medicines, Inijaq INN tofacitinib Marketing authorisation applicant Gedeon Richter Plc. Therapeutic indication Treatment of rheumatoid arthritis, psoriatic arthritis,…, Ruxolitinib Zentiva INN ruxolitinib Marketing authorisation applicant Zentiva k.s. Therapeutic indication Treatment of myelofibrosis (MF) in adults, treatment…, Start of re-examinations, KemSu INN sufentanil / ketamine - PUMA Marketing authorisation holder Proveca Pharma Limited Therapeutic indication Treatment of acute pain in children…, Meplyffa INN arimoclomol Marketing authorisation holder Zevra Denmark A/S More information Meplyffa : refusal Q&A, Qezzaqar INN catequentinib Marketing authorisation holder CATS Consultants GmbH Therapeutic indication Treatment of synovial sarcoma or leiomyosarcoma…, Outcome of re-examination, Xervyteg Therapeutic indication Treatment of allogeneic faecal microbiota, pooled More information Xervyteg : refusal Q&A Orphan medicine This…, Withdrawal of applications for initial application procedures, Zinmyleo INN trilaciclib Market authorisation applicant Pharmacosmos A/S More information Zinmyleo : Withdrawal, Isembyld INN apitegromab Market authorisation applicant Scholar Rock Netherlands B.V. More information Isembyld : Withdrawal, Positive recommendations on extensions of therapeutic indications , Abiraterone Mylan INN abiraterone acetate Marketing authorisation holder Mylan Pharmaceuticals Limited More information Abiraterone Mylan : pending EC…, Anzupgo INN delgocitinib Marketing authorisation holder Leo Pharma A/S More information Anzupgo : pending EC decision, Cosentyx INN secukinumab Marketing authorisation holder Novartis Europharm Limited More information Cosentyx : pending EC decision, Enhertu INN trastuzumab deruxtecan Marketing authorisation holder Daiichi Sankyo Europe GmbH More information Enhertu : pending EC decision, Jyseleca INN filgotinib Marketing authorisation holder Alfasigma S.p.A. More information Jyseleca : pending EC decision, Keytruda INN pembrolizumab Marketing authorisation holder Merck Sharp & Dohme B.V. More information Keytruda : pending EC decision, Ocrevus INN ocrelizumab Marketing authorisation holder Roche Registration GmbH More information Ocrevus : pending EC decision, Padcev INN enfortumab vedotin Market authorisation holder Astellas Pharma Europe B.V. More information Padcev : pending EC decision, Pepaxti INN melphalan flufenamide Marketing authorisation applicant Oncopeptides AB More information Pepaxti : pending EC decision, Sogroya INN somapacitan Marketing authorisation applicant Novo Nordisk A/S More information Sogroya : pending EC decision, Tecvayli INN teclistamab Marketing authorisation holder Janssen Cilag International More information Tecvayli : pending EC decision, Withdrawal of applications for recommendations on extensions of indications , Alhemo INN concizumab Market authorisation applicant Novo Nordisk A/S More information Alhemo : Withdrawal, Kaftrio INN ivacaftor / tezacaftor / elexacaftor Market authorisation applicant Vertex Pharmaceuticals (Ireland) Limited More information Kaftrio :…, Kalydeco INN Ivacaftor Market authorisation applicant Vertex Pharmaceuticals (Ireland) Limited More information Kalydeco : Withdrawal, Conclusion of Referrals, Ipidacrine-containing medicinal products INN ipidacrine More information Ipidacrine-containing medicinal products - referral News EMA concludes review of…, Sodium oxybate syrup and oral solution for alcohol dependence INN sodium oxybate More information Sodium oxybate-containing syrup and oral solution for alcohol…, Other updates, Pradaxa INN dabigatran etexilate Marketing authorisation applicant Boehringer Ingelheim International GmbH More information Pradaxa : pending EC decision