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

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 ...

Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.

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

At issue with Moderna's mRNA flu shot is communication from CBER to Moderna suggesting that the company’s vaccine be compared ...

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

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

The US Food and Drug Administration (FDA) has refused to review Moderna’s seasonal influenza jab, mRNA-1010, as the shifting vaccine landscape within the country continues to prove volatile for pharma ...

The Food and Drug Administration reversed course on Wednesday and agreed to formally review Moderna’s new flu vaccine that uses mRNA technology, the company announced in a news release. Earlier this ...

In December 2025, Moderna submitted an application to the FDA to approve the first mRNA-based flu vaccine. Catherine Falls Commercial/Moment via Getty Images Ana Santos Rutschman, Villanova University ...

The FDA will now review Moderna’s seasonal mRNA influenza vaccine application, setting a mid-2026 decision date. In a regulatory turnaround, the FDA will now review Moderna’s seasonal mRNA flu vaccine ...

Please provide your email address to receive an email when new articles are posted on . The FDA will now review an application for Moderna’s mRNA-1010 influenza vaccine. The agency initially rejected ...