The FDA has reversed course on Moderna’s mRNA influenza vaccine, agreeing to review a submission it previously refused, the company announced on Wednesday. Moderna said it has received a Prescription Drug User Fee Act (PDUFA) goal date of Aug. 5, 2026.
Credit: Moderna
After receiving a Refusal-to-File (RTF) letter from the FDA, Moderna scheduled a Type A meeting and proposed a revised regulatory approach for the vaccine. The proposed pathway was based on age, seeking approval for adults…
