The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended the approval of ten new medicines at its meeting in November 2025. Among the recommended medicines is Dawnzera (donidalorsen) from Otsuka Pharmaceutical Netherlands B.V. Dawnzera is for the prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. Other recommended drugs include GalenVita, Inluriyo, Teizeild, VacPertagen, Waskyra, Enzalutamide Accordpharma, Ondibta, Osqay, Teduglutide Viatris, and indication extensions for Koselugo, Minjuvi, Veyvondi, and Xerava, to name a few. The CHMP also expressed negative recommendations on some applications for extension of indications, for example for Hetlioz. Some applications were withdrawn or a re-examination was initiated. All recommendations will be submitted to the European Commission for a final decision on approval.