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

The U.S. Food and Drug Administration will review the investigational seasonal flu vaccine candidate after rejecting it earlier this month.

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

The U.S. Food and Drug Administration (FDA) recently informed Moderna that it would not review the company’s application for approval of its new flu vaccine, which is its first using mRNA technology ...

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

The FDA agreed to review Moderna’s experimental mRNA influenza vaccine after Moderna resubmitted its application with modifications.

(TNND) — The U.S. Food and Drug Administration is refusing to review Moderna’s application for approval of an mRNA-based flu vaccine, the latest step taken by the administration that might chill the ...

Moderna announced that the FDA agreed to review its application for a mRNA-based flu vaccine after it agreed to further study in older adults.

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.

The FDA will review Moderna’s new mRNA flu vaccine after reversing course, raising fresh concerns about potential setbacks ...