The FDA reversed a refusal-to-file decision and agreed to review Moderna’s seasonal flu vaccine mRNA-1010, setting a target PDUFA decision date of August 5. Moderna and CEO Stéphane Bancel presented a revised regulatory strategy that seeks full approval for adults 50–64 and accelerated approval for those 65+, with additional post-marketing study requirements for older adults. Reporting cited a Type A meeting between Moderna and the FDA as the proximate cause of the reversal; Politico also reported that a White House meeting between President Trump and FDA leadership occurred days earlier. The company framed the move as constructive regulatory engagement; unnamed sources described political pressure as a possible factor. This development reopens a regulatory pathway for an mRNA-based seasonal vaccine and shifts near-term timeline risk for competitors.