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

After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology.

The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA ...

This week, vaccine manufacturer Moderna revealed that Vinaya Prasad, the top vaccine regulator at the Food and Drug Administration (FDA)—which is a part of HHS— declined to even consider the safety ...

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

The Food and Drug Administration rejected Moderna's new flu shot. This raises questions about what it means for the future of vaccine development.

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

Moderna (MRNA) stock fell 9% premarket after FDA rejected its flu vaccine application due to trial design issues, despite ...

"The FDA rejected Moderna's application for filing because the company refused to follow very clear FDA guidance from 2024 to ...

Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA ...

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