EU CHMP flags five medicines for approval and 13 indication extensions at March 2026 meeting

At its March 2026 meeting, the EMA CHMP recommended five medicines for approval (Adstiladrin, Imdylltra, Joenja, Zepzelca, Bopediat), plus extensions of indication for 13 other medicines. It upheld its previous decision to refuse a change to Hetlioz’s marketing authorisation and noted withdrawal of Blarcamesine Anavex. In the Tecovirimat SIGA case, the committee concluded it should no longer be used for mpox. Other updates include a new subcutaneous route for Sarclisa and a biosimilar development reflection paper. The agenda and minutes will be published by EMA in coming weeks.