The U.S. Food and Drug Administration told Moderna it will accept and review the company’s biologics license application for its mRNA influenza vaccine mRNA-1010, assigning a PDUFA target date of Aug. 5, 2026. The decision follows a Type A meeting in which Moderna revised its regulatory approach after an initial refusal-to-file over trial comparator concerns. Moderna said it will pursue traditional approval for adults 50–64 and accelerated approval for those 65 and older with a required post-marketing study. The episode highlights regulatory volatility at the FDA and leaves timing for wider market access contingent on the agency’s review and any additional post-approval requirements.