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

Federal officials on Wednesday cast blame on Moderna as they stood by the Food and Drug Administration’s controversial ...

FDA Defends Flu Vaccine Decision ...

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

The agency said it denied Moderna’s application because it refused to follow “very clear” guidance. The drugmakers says the ...

Moderna received a surprise refusal from the FDA to review its updated flu vaccine, highlighting the ongoing struggle between vaccine makers and a vaccine-skeptical HHS.

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

The news is the latest sign of the FDA’s heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr.

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 ...

Prescription Drug User Fee Act (PDUFA) target action date set for September 28, 2026If approved, Ameluz® would be the first and only PDT ...