Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2025

16 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 16 medicines for approval at its April 2025 meeting.The CHMP recommended granting a…, Positive recommendations on new medicines , Alyftrek International non-proprietary name (INN) deutivacaftor / tezacaftor / vanzacaftor…, Attrogy INN diflunisal Marketing-authorisation applicant…, Duvyzat INN givinostat Marketing-authorisation applicant…, Sephience INN sepiapterin Marketing-authorisation applicant…, Tepezza INN teprotumumab Marketing-authorisation applicant…, Ziihera INN zanidatamab Marketing-authorisation applicant…, Positive recommendations on new biosimilar medicines , Dazublys INN trastuzumab Marketing-authorisation applicant…, Denbrayce INN denosumab Marketing-authorisation applicant…, Denosumab BBL INN denosumab Marketing-authorisation applicant…, Enwylma INN denosumab Marketing-authorisation applicant…, Izamby INN denosumab Marketing-authorisation applicant…, Junod INN denosumab Marketing-authorisation applicant…, Vevzuo INN denosumab Marketing-authorisation applicant…, Yaxwer INN denosumab Marketing-authorisation applicant…, Zadenvi INN denosumab Marketing-authorisation applicant…, Positive recommendation on new hybrid medicine , Oczyesa INN octreotide Marketing-authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Adcetris INN brentuximab vedotin Marketing-authorisation holder…, Adempas INN riociguat Marketing-authorisation holder…, Amvuttra INN vutrisiran Marketing-authorisation holder…, Calquence INN acalabrutinib Marketing-authorisation holder…, Cystadrops INN mercaptamine Marketing-authorisation holder…, Jivi INN damoctocog alfa pegol Marketing-authorisation holder…, Veklury INN remdesivir Marketing-authorisation holder…, Vyvgart INN efgartigimod alfa Marketing-authorisation holder…, Xofluza INN baloxavir marboxil Marketing-authorisation holder…, Zoonotic Influenza Vaccine Seqirus Common name zoonotic influenza vaccine (H5N8) (surface antigen, inactivated,…, Re-examination of initial marketing authorisation application , Kisunla INN donanemab Marketing-authorisation applicant…, Withdrawal of initial marketing authorisation application , Dazluma INN troriluzole Marketing-authorisation applicant…, Withdrawal of application to change the marketing authorisation , Ngenla INN somatrogon Marketing-authorisation holder…