Last mentioned: Mar 16, 2026
Anticipated PDUFA
Expected deadline for the FDA's final approval decision.
Regulatory Reversal
FDA agrees to review the application after Moderna addresses concerns.
Refusal to File
FDA issues an RTF citing deficiencies in the initial application.
BLA Submission
Moderna submits Biologics License Application for mRNA-1010.
Urgent warnings have been issued across 26 major outlets regarding dietary supplements sold on Amazon that were found to contain poisonous substances. The discovery of toxic contaminants in third-party products has reignited the debate over e-commerce liability and the safety of the largely unregulated supplement market.
The FDA has rescinded its initial refusal to file Moderna’s Biologics License Application for its seasonal flu vaccine, mRNA-1010.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.