The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu ...

Senior FDA official Vinay Prasad reportedly overrode his staff in deciding to reject Moderna's application for a new seasonal flu shot.

CEO Stephane Bancel said the letter refusing review did not cite ‘any safety or efficacy concerns’.

Routt County commissioners agreed this week to support the town of Hayden’s application for a state energy impact grant that ...

The Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with mRNA ...

The FDA has refused to review Moderna’s application for its messenger RNA-based influenza vaccine, according to the company.In a press release, Moderna noted that the FDA’s rejection of the vaccine, ...

The vaccine maker says the Food and Drug Administration has refused to review its application to sell a new seasonal flu ...

Spouses qualify for burial with the veteran even if the spouse remarried after the veteran's death. That detail surprises ...

The new shot was not compared to “the best-available standard of care in the United States at the time of the study,” an FDA ...

The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.

The company is “seeking clarity from the FDA on what has changed” from the previous written guidance it received, Moderna President Stephen Hoge said in an interview. “It’s a total surprise” the ...

HHS Spokesman Andrew Nixon told The National News Desk via email that the FDA rejected Moderna’s application for filing because “the company refused to follow very clear FDA guidance from 2024 to test ...