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

The US pharma firm’s 40,000-person study suggested its new shot was more effective than a standard flu vaccine.

The decision, which shocked company officials, comes as the FDA says it will take a stricter approach to federal vaccine ...

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

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

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

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

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

By Sneha S K Feb 10 (Reuters) - The U.S. Food and Drug Administration will not review Moderna's approval application for its ...

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

HealthDay News — In a major blow to vaccine development, the US Food and Drug Administration (FDA) said it will not review Moderna’s application for the first mRNA-based flu shot. Dr Vinay Prasad, the ...

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