In 2025, EMA recommended 104 medicines for marketing authorisation. Of these, 38 had a new active substance which had never been authorised in the European Union (EU) before. This includes medicines representing important innovation or contribution to public health, such as 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.

EMA also recommended 16 medicines for rare diseases, including the first medicine to treat Wiskott-Aldrich syndrome, a rare, inherited disease of the immune system, that affects almost exclusively males, and a disease-modifying gene therapy applied as a topical gel to treat wounds in patients of all ages with a rare condition that makes the skin very fragile (dystrophic epidermolysis bullosa).

EMA also adopted three positive opinions for medicines for use in countries…