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, ...

Presented by the Coalition to Strengthen America’s Healthcare{beacon} Health Care Health Care The Big Story FDA refuses ...

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

Moderna shares sink 10% after FDA issues Refusal-to-File letter for its mRNA-1010 flu vaccine, citing trial design concerns ...

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.

America’s drug safety agency declined to review a next-gen flu vaccine that uses the same tech as the coronavirus shots ...

A regulatory setback for Moderna’s next-generation flu vaccine underscores mounting scrutiny of late-stage trial design in the U.S., even as the company pivots to international manufacturing ...

The rejection is the latest instance of Vinay Prasad overruling career FDA scientists to place vaccines under harsher ...

Moderna said on Tuesday that the Food and Drug Administration (FDA) has refused to review its application for an mRNA flu vaccine, with the company claiming this decision is inconsistent with ...

Moderna said the move is inconsistent with previous feedback from the FDA on the experimental influenza shot, called ...

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has requested a Type A meeting to understand the path forwardmRNA-1010 has been ...