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

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 ...

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

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

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

Following a Type A meeting, the FDA's Center for Biologics Evaluation and Research has notified Moderna that its biologics ...

The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now ...

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.

"Pending FDA approval, we look forward to making our flu vaccine available later this year so that America's seniors have access to a new option to protect themselves against flu," Moderna CEO Stéphan ...

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

Reversing its initial decision, the FDA has agreed to review Moderna’s messenger RNA-based influenza vaccine for approval, the company announced Wednesday. The reversal about weeks after the FDA sent ...

Moderna said after a "Type A" meeting, the agency agreed to move forward and review its application for the mRNA-based shot.