Five new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2026 meeting.

The committee recommended granting a conditional marketing authorisation for Adstiladrin (nadofaragene firadenovec), for the treatment of adult patients with Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumours.

The CHMP recommended granting a marketing authorisation for Imdylltra (tarlatamab), a new treatment for relapsed extensive-stage small cell lung cancer which addresses an unmet medical need in adults with poor prognosis and limited treatment options. See more details in the news announcement in the grid below.

Joenja (leniolisib) received a positive opinion for a marketing authorisation under exceptional circumstances for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and…