Moderna says FDA refused to file its mRNA flu shot application, citing trial-design concer

Moderna says the FDA has declined to review (refused to file) its application for an experimental mRNA flu shot, triggering a public dispute over what the agency required for the submission. Coverage highlights Moderna’s objection to the FDA’s rationale and points to trial-design concerns—specifically the control arm used in the study—as a key issue raised in the company’s account of the refusal-to-file decision.