America’s drug safety agency declined to review a next-gen flu vaccine that uses the same tech as the coronavirus shots ...

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

The company revised its plan to seek full approval for middle-aged adults and accelerated approval for seniors.

After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out ...

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 says its experimental mRNA influenza vaccine, mRNA-1010, showed more than 30% greater relative vaccine efficacy against influenza A than a licensed egg-based flu shot in a large Phase 3 trial ...

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

The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel ...

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

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 the change Wednesday, about a week after revealing that the FDA’s vaccine chief was refusing to review the new vaccine, made with Nobel Prize-winning mRNA technology.

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