The U.S. Food and Drug Administration has reversed course and will review a new mRNA flu vaccine from Moderna, the pharmaceutical company said Wednesday.About two weeks ago, the FDA sent Moderna a ...

Ana Santos Rutschman does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations ...

Vinay Prasad, the Trump administration’s top vaccine regulator at the Food and Drug Administration, single-handedly decided to refuse to review Moderna’s mRNA flu vaccine, overruling agency scientists ...

The Food and Drug Administration has refused to review Moderna's application for its seasonal flu vaccine, the company announced on Feb. 10, marking the latest setback for the development of ...

Jason Mast is a general assignment reporter at STAT focused on the science behind new medicines and the systems and people that decide whether that science ever reaches patients. You can reach Jason ...

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast ...

The Food and Drug Administration (FDA) has refused to review an application by Moderna for its influenza mRNA vaccine, not due to issues with the shot itself but what the agency claims was substandard ...

The Food and Drug Administration on Wednesday defended its rejection of Moderna’s mRNA-based flu vaccine application, saying the company’s clinical trial design put patients at risk. The FDA’s defense ...

The Food and Drug Administration refused to review Moderna’s application for its new mRNA flu vaccine — a move the pharma giant’s’s president Dr. Stephen Hoge said left him in “complete shock.” In an ...

Federal officials on Wednesday cast blame on Moderna as they stood by the Food and Drug Administration’s controversial decision not to review the Cambridge biotech’s new flu vaccine. In a press ...

Update: The FDA reversed its decision on Feb. 18 and agreed to consider Moderna's application. Read the latest here. Our earlier story is below. The Food and Drug Administration is refusing to ...

Correction: This story was updated to clarify a statement given by Department of Health and Human Services spokesperson Andrew Nixon. Moderna said on Tuesday that the Food and Drug Administration (FDA ...