Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2025

13 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 13 medicines for approval at its July 2025 meeting.The committee recommended granting a…, CHMP statistics Key figures from the July 2025 CHMP meeting are represented in the graphic below., CHMP statistics: Text versionJuly 2025 statistics – monthly and cumulative figures for CHMP opinions and withdrawn applications:13 positive opinions on new medicines: 2 new non…, Positive recommendations on new medicines , Aqneursa International non-proprietary name (INN) L-Acetylleucine Marketing…, Ekterly INN sebetralstat Marketing authorisation applicant…, Romvimza INN vimseltinib Marketing authorisation applicant…, Tryngolza INN olezarsen Marketing authorisation applicant…, Voranigo INN vorasidenib Marketing authorisation applicant…, Yeytuo INN lenacapavir Marketing authorisation applicant…, Zurzuvae INN zuranolone Marketing authorisation applicant…, Positive recommendations on new biosimilar medicines , Bildyos INN denosumab  Marketing authorisation applicant…, Bilprevda INN denosumab Marketing authorisation applicant…, Eyluxvi INN aflibercept  Marketing authorisation applicant…, Usrenty INN ustekinumab Marketing authorisation applicant…, Positive recommendations on new generic medicines , Macitentan Accord INN macitentan Marketing authorisation applicant…, Macitentan AccordPharma INN macitentan Marketing authorisation applicant…, Positive recommendation on medicine for use outside the European Union , Lenacapavir Gilead INN lenacapavir Marketing authorisation applicant…, Withdrawal of initial marketing authorisation application , Aplidin INN plitidepsin Therapeutic indication…, Ifinwil INN eflornithine Marketing authorisation applicant…, Nidlegy INN bifikafusp alfa / onfekafusp alfa  Marketing authorisation…, Negative opinions of initial marketing authorisation applications , Elevidys INN delandistrogene moxeparvovec  Marketing authorisation applicant…, Jelrix INN autologous cartilage-derived articular chondrocytes, in-vitro expanded…, Nurzigma INN pridopidine  Marketing authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Alhemo INN concizumab Marketing authorisation holder…, Baqsimi INN glucagon Marketing authorisation holder…, Clopidogrel Zentiva INN clopidogrel Marketing authorisation holder…, Invokana INN canagliflozin Marketing authorisation holder…, mResvia INN single-stranded 5′ capped mRNA encoding the respiratory syncytial virus glycoprotein F stabilized in…, Sirturo INN bedaquiline Marketing authorisation holder…, Taltz INN ixekizumab Marketing authorisation holder…, Tevimbra INN tislelizumab Marketing authorisation holder…, Re-examinations of initial applications , Kisunla INN donanemab Marketing authorisation applicant…, Start of referral procedure , Tecovirimat SIGA INN tecovirimat More information…, Other updates Questions and answers on the outcome of assessment on use of Neuraceq to monitor treatment responseReference Number: EMA/310493/2020…