FDA Reverses Course, Will Review Moderna's mRNA Flu Vaccine

Moderna said the U.S. Food and Drug Administration has agreed to review its influenza vaccine, reversing an earlier decision to reject the application.
ZME Science on MSN

FDA Refuses To Review Moderna mRNA Flu Vaccine and the US Could Miss Out on Next Generation Fu Shots

In a rare and surprising move, the FDA has issued a “Refusal to File” letter for Moderna’s mRNA-1010 influenza vaccine. Moderna is a batch company that has now become a household name for helping to ...

Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna ...
USA Today

EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna’s mNEXSPIKE (COVID-19 Vaccine, mRNA)

CAMBRIDGE, MA / ACCESS Newswire / December 15, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has ...
The American Journal of Managed Care

FDA Reverses Course, Will Review Moderna’s mRNA Flu Vaccine

The FDA will now review Moderna’s seasonal mRNA influenza vaccine application, setting a mid-2026 decision date.