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Moderna said on the FDA has agreed to review its influenza vaccine, reversing an earlier decision to reject the application.

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

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.

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.

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

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

Moderna said on Wednesday the U.S. drug regulator will review its modified flu vaccine application, a week after rejecting the original submission.

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