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

The Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with mRNA technology, the company said.

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.

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

Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S.

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.

Add Yahoo as a preferred source to see more of our stories on Google. The dispute centers on what Moderna compared its vaccine against in its clinical trial: The FDA says Moderna used a flu shot that ...

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. The post FDA to review Moderna's mRNA flu vaccine after initial ...

At issue with Moderna's mRNA flu shot is communication from CBER to Moderna suggesting that the company’s vaccine be compared against a control shot designed more specifically for older people.

Moderna (MRNA) is back in focus after completing a clinical study of multiple mRNA vaccines targeting several respiratory ...

WASHINGTON—In an hour-long meeting in January, Food and Drug Administration career staff laid out their objections to a plan to block a new flu shot from vaccine maker Moderna. They argued that ...

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 ...