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 ...

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

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

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

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

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

FDA Commissioner Dr. Marty Makary discusses the crackdown on GPL-1 drugs and Moderna's new mRNA flu vaccine on 'Mornings with Maria.' ...

Moderna announced the change Wednesday, about a week after revealing that the FDA’s vaccine chief was refusing to review the new vaccine, made with Nobel Prize-winning mRNA technology.

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

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 ...