European Medicines Agency approvals of new medicines in March and April 2025

In March and April of 2025, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the granting of an EU-wide marketing authorisation for 8 new medicines (Table 1) and 12 new biosimilar products (Table 2). The CHMP also recommended the marketing authorisation of one new generic medicine and extensions of the indication for 17 medicinal products already authorised in the EU.2,3