The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval for three new orphan medicines and declined to endorse two programs previously cleared by the FDA, according to BioCentury. The CHMP also issued a positive recommendation for Moderna’s combined flu–COVID vaccine, further separating European and U.S. regulatory outcomes on contemporaneous dossiers. The CHMP recommendations will move to the European Commission for final decisions. Regulators’ divergent stances on orphan and specialty products underline persistent global differences in evidentiary thresholds and market access expectations.