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

The agency previously told Moderna its application did not contain an “adequate and well-controlled” trial.

The Food and Drug Administration has reversed course and agreed to review Moderna’s application for the first mRNA-based flu vaccine under a revised approach, company and federal officials said ...

After initially rejecting Moderna’s application for review, the FDA will now consider the company’s mRNA flu shot ...

Moderna's new flu vaccine application will be reviewed by the FDA after a dispute regarding clinical trial parameters was ...

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 US Food and Drug Administration's (FDA’s) Center for Biologics Evaluation and Research (CBER) is refusing to review Moderna’s application for approval of a new flu vaccine. The decision comes ...

The number of people getting sick with influenza B has gone up for three weeks straight, now making up about a third of flu cases nationwide.

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.

The US Food and Drug Administration has reversed course and will review a new mRNA flu vaccine from Moderna, the pharmaceutical company said Wednesday, ...