Human medicines in 2025 / 104 new medicines recommended for approval; 38 had a new active substance
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 [...]






























