Moderna said it met with the FDA on Tuesday to discuss the vaccine and afterward, the U.S. regulator accepted a revised ...

With the reversal from the FDA, Moderna said it is aiming to make the vaccine available for the 2026-27 flu season.

The FDA agreed to review Moderna’s experimental mRNA influenza vaccine after Moderna resubmitted its application with modifications.

The Food and Drug Administration has reversed its shocking refusal to consider Moderna’s mRNA flu vaccine for approval.

Moderna announced that the FDA will review its new mRNA flu vaccine, a reversal less than two weeks after the agency refused ...

Moderna's mRNA-1010 flu vaccine for older adults could be made available by the end of 2026, the pharmaceutical company ...

The FDA is slated to make a decision on the flu shot on Aug. 5, which will allow Moderna to make the vaccine available for the upcoming influenza season.

Moderna held further discussions with regulators and announced that the agency would accept the company’s application for approval of its flu vaccine that uses mRNA technology.

The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA ...

The FDA will review Moderna’s new mRNA flu vaccine after reversing course, raising fresh concerns about potential setbacks ...

By Mariam Sunny and Michael Erman Feb 18 (Reuters) - Moderna said on Wednesday the U.S. Food and Drug Administration changed course and will review an amended application for its new flu vaccine, a ...

FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying it contradicts prior FDA guidance.