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

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

One week after saying it was refusing to review Moderna’s application for approval of a new flu vaccine, the US Food and Drug Administration's (FDA’s) Center for Biologics Evaluation and Research ...

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.

Stéphane Bancel, Moderna’s chief executive officer, said that “we appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application ...

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

The flu vaccine is its first using mRNA technology for influenza.

The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA flu vaccine candidate after holding a high-priority meeting with the company.

Moderna says the U.S. Food and Drug Administration (FDA) has agreed to review its influenza ‌vaccine, reversing an earlier decision to reject the application, following modifications from the company.

HHS Spokesman Andrew Nixon told The National News Desk via email that the FDA rejected Moderna’s application for filing ...

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

The FDA reversed course and told Moderna it would review its application for a new flu vaccine, the company announced ...