In 2025, the European Medicines Agency (EMA) recommended 104 medicines for marketing authorisation, including 38 with new active substances never before approved in the EU. These featured major innovations, such as the first treatments for non-cystic fibrosis bronchiectasis, delaying stage 3 type 1 diabetes, and an oral therapy for postpartum depression.

EMA also recommended 16 medicines for rare diseases, including the first treatment for Wiskott–Aldrich syndrome and a gene therapy gel for dystrophic epidermolysis bullosa. Additionally, three positive opinions were issued for medicines intended for use outside the EU, including a twice-yearly injectable HIV PrEP treatment.

The agency recommended 41 new biosimilars to help reduce costs and improve access to essential medicines. The 2025 overview highlights key authorisations, therapeutic advances, and safety-related regulatory actions, as EMA and EU Member States continue to monitor authorised medicines for quality and benefit–risk balance.