Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2026
Amsterdam, The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the outcomes of its meeting held on 18-21 May 2026, recommending eight new medicines for approval and expanding the therapeutic scope of 13 existing treatments.
The committee adopted positive opinions for novel therapies addressing high unmet needs. Jascayd (nerandomilast) was recommended for idiopathic and progressive pulmonary fibrosis (IPF/PPF), offering a new option for these life-threatening lung diseases. In a milestone for rare diseases, Vijoice (alpelisib) received a positive opinion for conditional approval for severe PIK3CA-related overgrowth spectrum (PROS), a genetic disorder with no previously authorised medicine.
In oncology, the CHMP endorsed Etcamah (camizestrant) for ESR1-mutated breast cancer and recommended approval for the biosimilar Vislyfa (ranibizumab). Other recommendations included Boey (trenibotulinumtoxinE) for glabellar lines and hybrid applications for Ablymico (weight management) and Liraglutide STADA (diabetes).
A major update concerns Wegovy (semaglutide), with the CHMP recommending the authorisation of a daily oral tablet formulation for weight management, providing an alternative to weekly injections.
The committee did not recommend approval for the diagnostic agent Deqtynet. Applications for Orblid and Veblocema were withdrawn.
