12 new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its September 2026 meeting.

The committee recommended granting a marketing authorisation for Frehemgo (denecimig), for the prophylaxis of bleeding episodes in patients with haemophilia A, an inherited bleeding disorder caused by a lack of factor VIII, a protein that helps blood clot.

Gevalka (ensartinib) received a positive opinion from the CHMP for the treatment of adult patients with anaplastic lymphoma kinase positive advanced non-small cell lung cancer.

The CHMP recommended granting a marketing authorisation for Klygefa (gefurulimab) for the treatment of adult patients with generalised myasthenia gravis, a disease that leads to muscle weakness and tiredness.

The committee adopted a positive opinion for Lifyorli (relacorilant), for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Povofortay…