Last mentioned: 3d ago
Anticipated PDUFA
Expected deadline for the FDA's final approval decision.
FDA U-Turn
FDA agrees to review the application after resolving the public dispute.
Regulatory Reversal
FDA agrees to review the application after Moderna addresses concerns.
Political Controversy
Reports emerge that the vaccine chief overruled career scientists to block the shot.
Refusal to File
FDA issues a shocking rejection of the application, sparking a public dispute.
Refusal to File
FDA issues an RTF citing deficiencies in the initial application.
BLA Submission
Moderna submits Biologics License Application for mRNA-1010.
Initial BLA Submission
Moderna submits its Biologics License Application for mRNA-1010.
The FDA has rescinded its initial refusal to file Moderna’s Biologics License Application for its seasonal flu vaccine, mRNA-1010.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.
Moderna has confirmed that the FDA will officially review its mRNA-based influenza vaccine following a highly publicized regulatory standoff. The reversal comes after reports that the Trump administration's vaccine leadership initially overruled career scientists to block the application.