FDA delays approval for Moderna RSV vaccine

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Moderna, Inc. (NASDAQ:MRNA) today announced it has been notified by the U.S. Food and Drug Administration (FDA) that due to administrative constraints, the agency does not expect to complete its review of the Biologics License Application (BLA) for mRNA-1345, Moderna’s investigational respiratory syncytial virus (RSV) vaccine, by the previously communicated Prescription Drug User Fee Act (PDUFA) date of May 12, 2024. The FDA has informed Moderna that it is working to conclude the review by the end of May 2024.

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h/t A Deplorable Neanderthal

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