September 18, 2026 — The European Medicines Agency's human medicines committee (CHMP) recommended 12 new medicines for approval at its September 2026 meeting, alongside positive opinions for extensions of therapeutic indications for 11 already-authorised medicines.
New Medicine Recommendations
Among the notable recommendations, the CHMP backed Frehemgo (denecimig) for preventing bleeding episodes in haemophilia A patients, and Gevalka (ensartinib) for ALK-positive advanced non-small cell lung cancer.
Klygefa (gefurulimab) was recommended for generalised myasthenia gravis, while Lifyorli (relacorilant) received a positive opinion for platinum-resistant ovarian cancer.
Povofortay (povorcitinib) became the first oral daily treatment recommended for hidradenitis suppurativa in adults refractory to anti-TNF therapy. Sepalna (senaparib) was recommended as maintenance therapy for advanced ovarian cancer.
VaxRabeo, a rabies vaccine, was recommended for all age groups, and Zeydovio (glepaglutide) for short bowel syndrome.
Two biosimilars were endorsed: Adcomfo (omalizumab) for asthma and chronic urticaria, and Pebrilzo (pertuzumab) for breast cancer. Two generics — Inijaq (tofacitinib) and Ruxolitinib Zentiva — also received positive opinions.
Indication Extensions
The CHMP recommended extending Anzupgo to adolescents aged 12+ for chronic hand eczema, plus expansions for 10 other medicines including Cosentyx, Enhertu, Keytruda, and Ocrevus.
Other Actions
Three initial marketing authorisation applications were withdrawn, including Isembyld for spinal muscular atrophy. Three indication extension applications were also withdrawn. Re-examination requests were filed for Kemsu, Meplyffa, and Qezzaqar following negative opinions in July 2026. The committee confirmed its refusal of Xervyteg for acute graft-versus-host disease.
