After issuing a refuse‑to‑file letter, the FDA agreed to accept Moderna’s BLA for its mRNA influenza vaccine mRNA‑1010 and set a PDUFA target of Aug. 5, 2026. The agency and Moderna negotiated an age‑stratified review approach: full approval sought for adults 50–64 and accelerated approval for adults 65+, with a required post‑marketing study in older adults. Agency sources said the reversal followed a Type A meeting in which Moderna proposed an amended regulatory strategy; the episode spotlighted tensions inside vaccine review staff and drew industry attention to decision‑making at senior levels. Moderna framed the move as constructive engagement with regulators and reaffirmed timelines for a possible 2026–27 season submission. The episode underscores regulatory unpredictability for high‑visibility vaccines and sets a near‑term milestone for mRNA platform expansion into seasonal influenza.