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

The company’s mRNA flu shot, if approved, could be available for the 2026-27 flu season.

Moderna announced that the FDA agreed to review its application for a mRNA-based flu vaccine after it agreed to further study ...

Vaccine maker Moderna says the Food and Drug Administration will decide whether to approve its new flu shot for older adults ...

The Food and Drug Administration's about-face comes a little more than a week after the agency refused to consider the ...

Two weeks ago, the FDA took the rare step of refusing to accept Moderna’s application for its first mRNA flu vaccine. After ...

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

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

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

President Trump called Commissioner Marty Makary to the White House to discuss his frustration with the agency handling of ...

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