BioCentury

EMA’s CHMP Recommends Three New Orphan Drugs, Rebuffs Two FDA-Approved Programs

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines, including three orphan drugs already approved by the FDA—Ojemda for pediatric low‑grade glioma, Palsonify for acromegaly, and Xolremdi for WHIM syndrome. The agency also gave a positive opinion to Moderna’s combined flu‑COVID‑19 mRNA vaccine, diverging from the FDA’s recent refusal to file the standalone flu candidate. Additionally, CHMP rejected two therapies that the FDA had previously declined, underscoring a regulatory split between Europe and the United States.