EMA’s CHMP backs three orphan drugs — rejects two FDA‑cleared programs

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of three new orphan medicines and declined support for two programs previously cleared by the FDA, per BioCentury reporting. The CHMP also issued a positive opinion on Moderna’s combined flu–COVID vaccine in the same review cycle. The CHMP recommendations will go to the European Commission for final decisions. The divergent outcomes between EMA and FDA for certain orphan programs highlight cross‑jurisdictional differences in evidentiary standards and could affect sponsor filing strategies in 2026.