Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 May 2025

Ten new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended ten medicines for approval at its May 2025 meeting.The committee recommended granting…, Positive recommendations on new medicines , Aucatzyl International non-proprietary name (INN) obecabtagene autoleucel…, Blenrep INN belantamab mafodotin  Marketing-authorisation applicant…, Ezmekly INN mirdametinib Marketing-authorisation applicant…, Itovebi INN inavolisib Marketing-authorisation applicant…, Maapliv INN amino acids Marketing-authorisation applicant…, Positive recommendations on new biosimilar medicines , Bomyntra INN denosumab  Marketing-authorisation applicant…, Conexxence INN denosumab Marketing-authorisation applicant…, Rolcya INN denosumab Marketing-authorisation applicant…, Positive recommendation on new hybrid medicine , Riulvy INN tegomil fumarate  Marketing-authorisation applicant…, Positive recommendation on new generic medicine , Emtricitabine/Tenofovir alafenamide Viatris INN emtricitabine / tenofovir alafenamide…, Withdrawal of initial marketing authorisation application , Teriparatide Ascend INN teriparatide Marketing-authorisation applicant…, Negative opinion of initial marketing authorisation application , Atropine sulfate FGK INN atropine Marketing-authorisation applicant…, Kinselby INN resminostat mesilate Marketing-authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Imfinzi INN durvalumab Marketing-authorisation holder…, Rezolsta INN darunavir / cobicistat  Marketing-authorisation holder…, Saxenda INN liraglutide Marketing-authorisation holder…, Tevimbra INN tislelizumab Marketing-authorisation holder…, Withdrawal of extension of indication , Lutathera INN lutetium Marketing-authorisation applicant…, Re-examination of recommendations , Aplidin INN plitidepsin  More information…, Winlevi INN clascoterone More information Winlevi…, Start of referral procedure , Ipidacrine INN ipidacrine More information EMA…, Outcome of referral procedure , Azithromycin containing medicinal products for systemic use INN various More…, Other updates , Start of Union reviews adopted during the CHMP meeting of 19-22 May 2025AdoptedReference Number: EMA/170235/2025 English (EN…