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

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's about-face comes a little more than a week after the agency refused to consider the ...

Moderna announced that the FDA agreed to review its application for a mRNA-based flu vaccine after it agreed to further studies. Federal officials did not immediately comment.

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

Moderna’s stock was surging after the FDA said it would review the biotech’s flu-vaccine candidate, a week after it had ...

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

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