In 2025, the European Medicines Agency (EMA) recommended 104 medicines for marketing authorisation, 38 of which had a new active substance which had never been authorised in the European Union (EU) before.  

These included the first medicine to treat non-cystic fibrosis bronchiectasis, a first-in-class treatment to delay the onset of stage 3 type 1 diabetes in children and adults, and the first oral medicine to treat postpartum depression following childbirth. 

This is according to the EMA’s overview of the 2025 key recommendations, which includes figures on the authorisation of medicines and a selection of new treatments that represent significant progress in their therapeutic areas. 

EMA also recommended 16 medicines for rare diseases, including the first medicine to treat Wiskott-Aldrich syndrome and a disease-modifying gene therapy to treat wounds in patients of all ages with dystrophic epidermolysis bullosa. 

EMA also adopted three positive opinions for medicines for use in countries outside the EU, including a medicine for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents. This medicine will facilitate PrEP uptake and compliance because it only has to be administered twice a year via a subcutaneous injection. 

In addition, there were 41 recommendations for new biosimilar products, which EMA describes as “a core part of the healthcare system for managing costs and expanding access to essential treatments”.

Diana Turner, Deputy Editor, DDW