The FDA reversed an earlier refusal‑to‑file decision and agreed to review Moderna’s seasonal mRNA flu vaccine mRNA‑1010, setting a PDUFA target of Aug. 5. Moderna said the agency accepted a revised regulatory plan that would seek full approval in ages 50–64 and accelerated approval in those 65+, with post‑marketing study commitments for older adults. BioCentury and other outlets reported that the reversal followed heightened engagement between industry and regulators, with Politico citing a White House call to FDA leadership; both the FDA and White House have publicly denied direct orchestration. The agency’s new path for mRNA‑1010 resets timing for market access and keeps regulatory scrutiny of mRNA vaccines squarely in focus.