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

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

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 ...

Moderna took the unusual step of announcing the FDA’s refusal and releasing the agency’s letter. The letter states that Moderna did not conduct an “adequate and well-controlled” study because it had ...

Mani Foroohar, M.D., of Leerink Partners, says that the decision reflects “how sharp the departure has been between the prior ...

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

Moderna noted the FDA did not identify any specific safety concerns with the vaccine and that the rejection was inconsistent ...

Moderna’s mRNA influenza vaccine faces US regulatory delays after a refusal-to-file letter from top FDA official Dr Vinay Prasad.

Moderna said its new flu shot has been cleared for review in Australia, Canada and the European Union. It has asked to meet ...

Moderna received what’s called a “refusal-to-file” letter from the FDA that objected to how the company conducted a ...

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