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

After an initial rejection, the FDA will review Moderna’s mRNA flu vaccine for adults 50+, aiming for approval by the 2026-27 ...

The FDA has accepted Moderna’s revised influenza vaccine filing days after controversially refusing to review the original submission, putting the biotech on track to win approval in time for the 2026 ...

The recommendation from regulators paves the way for the shot’s approval in the European Union at a time the company is ...

In issuing a positive recommendation, the EMA has diverged from the FDA, which has set higher approval standards for ...

The company’s mRNA flu shot, if approved, could be available for the 2026-27 flu season.

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

Moderna said the U.S. Food and Drug Administration has agreed to review its influenza vaccine, reversing an earlier decision to reject the application.

Reversing its initial decision, the FDA has agreed to review Moderna’s messenger RNA-based influenza vaccine for approval, the company announced Wednesday. The reversal about weeks after the FDA sent ...

Moderna said after a "Type A" meeting, the agency agreed to move forward and review its application for the mRNA-based shot.