FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying ...

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

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

After the FDA's surprise refusal to take up a review of Moderna's next-gen flu vaccine, the public disagreement between U.S.

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

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 rejected Moderna's new flu shot. This raises questions about what it means for the future of vaccine development.

To help answer common vaccine questions, we consulted Dr. Stanley Perlman, a professor at the University of Iowa’s Carver College of Medicine and a member of the U.S. Food and Drug Administration’s ...

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