PFE - FDA Delays 'Important' Moderna Vaccine Review: William Blair Says 2025 Growth '2026 Breakeven Story' Depends On It | Benzinga
The Food and Drug Administration (FDA) notified Moderna Inc (NASDAQ:MRNA) on Friday that its review of a new vaccine has been delayed.
The agency, citing administrative constraints, 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 Prescription Drug User Fee Act date of May 12, 2024.
The FDA has informed Moderna that it is working to conclude the review by the end of May 2024.
The FDA has not informed Moderna of any issues related to vaccine safety, efficacy, or quality that would prevent the approval of mRNA-1345.
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