Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025

14 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its September 2025 meeting.The committee recommended…, CHMP statistics , CHMP statistics: Text versionSeptember 2025 statistics – monthly and cumulative figures for CHMP opinions and withdrawn applications:14 positive opinions on new medicines: 4…, Positive recommendations on new medicines , Enflonsia International non-proprietary name (INN) clesrovimab Marketing…, Imaavy INN nipocalimab Marketing authorisation applicant…, Kyinsu INN insulin icodec / semaglutide  Marketing authorisation applicant…, Lynkuet INN elinzanetant Marketing authorisation applicant…, Positive recommendations on new biosimilar medicines , Acvybra INN Denosumab Marketing authorisation applicant…, Degevma INN denosumab Marketing authorisation applicant…, Denosumab Intas INN denosumab Marketing authorisation applicant…, Gobivaz INN golimumab  Marketing authorisation applicant…, Kefdensis INN denosumab Marketing authorisation applicant…, Ponlimsi INN denosumab Marketing authorisation applicant…, Usgena INN ustekinumab Marketing authorisation applicant…, Xbonzy INN denosumab Marketing authorisation applicant…, Zvogra INN denosumab Marketing authorisation applicant…, Positive recommendations on new generic medicines , Rivaroxaban Koanaa INN rivaroxaban Marketing authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Bimervax INN COVID-19 vaccine  Marketing authorisation holder…, Dupixent INN dupilumab Marketing authorisation holder…, Keytruda INN pembrolizumab Marketing authorisation holder…, Koselugo INN selumetinib Marketing authorisation holder…, Tezspire INN tezepelumab Market authorisation holder…, Uplizna INN inebilizumab Marketing authorisation holder…, Withdrawal of initial marketing authorisation application , Fanskya INN mozafancogene autotemcel Market authorisation applicant…, Amtagvi INN lifileucel Market authorisation applicant…, Tuzodi INN Midazolam Marketing authorisation applicant…, Omforro INN Midazolam Marketing authorisation applicant…, Re-examinations of initial applications , Atropine sulfate FGK INN atropine Marketing authorisation applicant…, Winlevi INN clascoterone Marketing authorisation applicant…, Other updates , Questions and answer on the outcome of assessment on use of Lutathera in treatment of gastro-entero-pancreatic neuroendocrine tumours in adolescentsReference Number: EMA/299422/…, Lunsumio INN mosunetuzumab Marketing authorisation holder…, Norvir INN ritonavir Market authorisation holder…