Seven new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2025 meeting.

The committee recommended granting a conditional marketing authorisation for Anktiva (nogapendekin alfa inbakicept), for the treatment of adults with a type of bladder cancer that affects the lining of the bladder (non-muscle invasive bladder cancer, NMIBC) and that is at high risk of growing and spreading. Bladder cancer is one of the most common cancers in the European Union (EU), affecting over 200,000 people each year, with most cases being NMIBC. See more details in the news announcement in the grid below.

The CHMP recommended granting a marketing authorisation for Aumseqa (aumolertinib), for the treatment of EGFR-mutated non-small cell lung cancer.

Exdensur (depemokimab) received a positive opinion from the CHMP for the treatment of a particular type of asthma called severe eosinophilic asthma, and for severe chronic…