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

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

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 Food and Drug Administration has reversed its shocking refusal to consider Moderna’s mRNA flu vaccine for approval.

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 disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now ...

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

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

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

The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA ...

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 claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA ...