FDA

regulator

Last mentioned: 4d ago

Timeline

  1. Anticipated PDUFA

    Expected deadline for the FDA's final approval decision.

  2. Regulatory Reversal

    FDA agrees to review the application after Moderna addresses concerns.

  3. Refusal to File

    FDA issues an RTF citing deficiencies in the initial application.

  4. BLA Submission

    Moderna submits Biologics License Application for mRNA-1010.

Stories mentioning FDA 1

fda-approval Bullish

FDA Reverses Course, Agrees to Review Moderna’s mRNA Flu Vaccine

The FDA has rescinded its initial refusal to file Moderna’s Biologics License Application for its seasonal flu vaccine, mRNA-1010. This rare regulatory pivot clears the path for a formal review of the first mRNA-based influenza shot, a critical milestone for Moderna’s post-pandemic growth strategy.

2 sources