The U.S. Food and Drug Administration agreed to rescind a prior refuse‑to‑file posture and will review Moderna’s seasonal flu candidate mRNA‑1010 after a Type A meeting, the company said, with a target PDUFA action date of August 5. Moderna proposed an age‑stratified approval pathway that includes full approval in adults 50–64 and an accelerated approval pathway for those 65 and older tied to post‑marketing commitments. Moderna’s announcement followed rapid engagement with regulators; press coverage also reported that a White House conversation played a role in accelerating the process, a characterization the White House denied. The reversal has already moved Moderna shares, reflecting renewed investor focus on vaccine franchises. The FDA’s decision to review mRNA‑1010 reintroduces competition in the mRNA vaccine space and will test agency comfort with differentiated regulatory pathways tied to age and post‑market studies.