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

The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel ...

The FDA is slated to make a decision on the flu shot on Aug. 5, which will allow Moderna to make the vaccine available for the upcoming influenza season.

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

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said Tuesday, in another setback for the technology ...

The Food and Drug Administration rejected Moderna’s application for its mRNA-based flu vaccine, the drugmaker said Tuesday ...

Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA communications and went against the regulator’s established guidance for flu shots.