EMA Panel Backs 8 New EU Drugs, Including Tablet Wegovy, and Rejects 1
Updated
Updated · MedWatch · May 22
EMA Panel Backs 8 New EU Drugs, Including Tablet Wegovy, and Rejects 1
3 articles · Updated · MedWatch · May 22
Eight new medicines won positive CHMP opinions after the EMA’s May meeting, including Novo Nordisk’s tablet Wegovy, clearing them to move toward EU marketing authorization.
The recommendations span major unmet needs: Jascayd for idiopathic and progressive pulmonary fibrosis, conditional approval for Vijoice in severe PIK3CA-related overgrowth syndromes, and Etcamah for ESR1-mutated advanced breast cancer.
Three hybrid medicines also received backing—Ablymico for weight management, Liraglutide STADA for type 2 diabetes, and Colchicine AGEPHA Pharma for stable coronary artery disease—while biosimilar Vislyfa was endorsed for sight-threatening eye diseases.
One product, Deqtynet, was recommended for refusal as a PET diagnostic for adult neuroendocrine tumors, showing the committee’s review was not uniformly positive.
The panel also supported expanded indications for 13 already approved medicines, including Keytruda, Enhertu and Wegovy, broadening the EU treatment landscape beyond the new-drug decisions.
A new cancer diagnostic was blocked by EU market rules. When does protecting innovation end up harming patients?
If stopping weight-loss drugs means regaining the weight, are we trading obesity for lifelong drug dependency?
As weight-loss drugs change our diets, is the food industry truly adapting for health or just for profit?
EMA May 2026: 8 New Drug Approvals, 13 Indication Extensions, and a Landmark Oral Obesity Pill for the EU
Overview
In May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded its meeting by issuing several important recommendations for new medicine approvals and rejections. These recommendations are now sent to the European Commission, which usually makes final decisions within two to three months. The outcomes of this meeting highlight both significant advancements in therapeutic options and a notable rejection, reflecting the EMA’s rigorous approach to evaluating new treatments. This process ensures that only medicines meeting high standards of efficacy and safety move forward, shaping the future of healthcare in the European Union.