CHMP recommends 12 medicines for approval at September 2026 meeting

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval at its 14–17 September 2026 meeting, according to the supplied meeting highlights. The committee also issued positive recommendations to extend therapeutic indications for 11 medicines.

The new-medicine recommendations included gefurulimab (Klygefa) for adults with generalised myasthenia gravis and glepaglutide (Zeydovio) for adults with short bowel syndrome. Other products listed included denecimig, ensartinib, relacorilant, povorcitinib, senaparib and an inactivated rabies vaccine. The two biosimilars were omalizumab (Adcomfo) and pertuzumab (Pebrilzo); the two generics were tofacitinib (Inijaq) and Ruxolitinib Zentiva.

The highlights also listed the start of re-examinations for KemSu, Meplyffa and Qezzaqar, and withdrawals of initial applications for trilaciclib (Zinmyleo) and apitegromab (Isembyld). These committee recommendations should not be interpreted as final marketing authorisations. The supplied extract contains incomplete indication descriptions and no supporting efficacy or safety results; full regulatory documents are needed to establish precise eligible populations and prescribing implications.