Meeting highlights from the Co... Note

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

The European Medicines Agency's (EMA) human medicines committee (CHMP) recommended 13 new medicines for approval at its July 2025 meeting. The committee granted positive opinions on 13 new medicines, including Aqneursa, Ekterly, Romvimza, Tryngolza, Voranigo, Yeytuo, and Zurzuvae. Additionally, the CHMP recommended four new biosimilar medicines, including Bildyos, Bilprevda, Eyluxvi, and Usrenty. Three new generic medicines, Macitentan Accord and Macitentan AccordPharma, were also recommended for approval. The committee also gave a positive recommendation for Lenacapavir Gilead for use outside the European Union. Furthermore, the CHMP issued negative opinions on four initial marketing authorization applications, including Elevidys, Jelrix, Nurzigma, and withdrew three initial marketing authorization applications, including Aplidin, Ifinwil, and Nidlegy. The committee also recommended extensions of therapeutic indications for several medicines, including Alhemo, Baqsimi, Clopidogrel Zentiva, Invokana, mResvia, Sirturo, Taltz, and Tevimbra.