In 2025, the FDA approved more new drugs than the European Medicines Agency (EMA), although both agencies saw a decrease compared to 2024.[4] The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of 44 new medicines or vaccines by November 2025, significantly less than the 64 positive recommendations in 2024.[4] This decline is related to reforms in the area of prices and access to medicines in the US and the EU.[4] Notable approvals in 2025 include drugs such as fitusiran (Qfitlia) from Sanofi and Alnylam Pharmaceuticals for the treatment of hemophilia, approved by the FDA in March 2025,[4] and datopotamab deruxtekan-dlnk (AstraZeneca/Daiichi Sankyo) approved by the FDA on January 17, 2025 for the treatment of patients with certain types of cancer.[3] In the first and second quarters of 2025, new indications for existing biologics and biosimilars were mostly approved, rather than entirely new drugs.[1][2] The difference between the FDA and the EMA is also visible in the approval of orphan drugs - in 2024, the FDA approved 26 orphan drugs (52% of the total), while the EMA only 15 (33%).[5]