Moderna said it met with the FDA on Tuesday to discuss the vaccine and afterward, the U.S. regulator accepted a revised application seeking full approval of the shot for adults ages 50 to 64, and ...

The Food and Drug Administration will consider whether to approve Moderna’s new flu vaccine after all, resolving a dispute that had blocked the company’s application for the first-of-its-kind shot.

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.

Add Yahoo as a preferred source to see more of our stories on Google. The US medical regulator denied Moderna’s application for a review of its first mRNA flu vaccine. The US pharma firm produced ...

Six years after early vaccine trials, the legacy of COVID-19 shots reflects science, public debate, and how perceptions ...

Questions about the COVID-19 shot abound as federal recommendations shift and medical groups issue clashing guidance.

The Cambridge-based drug maker said the deal settles "all worldwide" litigation related to certain drugs and it won't have to pay royalties to other companies.

The Food and Drug Administration has refused to review an application from the biotech company Moderna to approve its mRNA-based flu vaccine. The agency’s decision, which Moderna announced in a press ...

The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday. The news is the ...

Vinay Prasad’s exit — his second from the agency in less than a year — comes after sharp criticism of his handling of drug ...

The Food and Drug Administration’s vaccine chief, Dr. Vinay Prasad, will depart the agency next month, an FDA spokesperson ...