FDA reverses course, agrees to review Moderna’s mRNA flu vaccine 

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.  After receiving a Refusal-to-File (RTF) letter from the FDA, Moderna scheduled a Type A… The post FDA reverses course, agrees to review Moderna’s mRNA flu vaccine  appeared first on Drug Discovery and Development.

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