The FDA reversed a recent refusal-to-file and agreed to review Moderna’s mRNA seasonal influenza vaccine mRNA-1010, assigning a PDUFA target date of Aug. 5, 2026. Moderna will seek full approval for adults 50–64 and accelerated approval for those 65+, with a required post-marketing study in older adults, the company said. The agency’s change follows a Type A meeting in which Moderna proposed an amended regulatory approach and agreed to additional data commitments. The reversal reduces immediate regulatory risk for Moderna but leaves open patent and broader policy uncertainties as the regulator navigates high-profile vaccine reviews under new leadership.