The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended three new orphan drugs and declined approval for two programs previously cleared by the FDA, BioCentury reported. The CHMP also issued a positive recommendation for Moderna’s combined influenza–COVID mRNA vaccine. The CHMP’s divergent decisions underscore regulatory differences between the EU and U.S., creating tactical challenges for global developers on trial design, submission sequencing, and commercialization timing. Companies with split outcomes will need targeted engagement with EMA to address the CHMP’s concerns or to plan additional studies. The recommendations will shape market access strategies for orphan indications in Europe and highlight that FDA approval does not guarantee EMA acceptance, particularly for specialized or accelerated programs.