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

In a rare and surprising move, the FDA has issued a “Refusal to File” letter for Moderna’s mRNA-1010 influenza vaccine.

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

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 ...

Moderna said it’s requesting a meeting with the U.S. Food and Drug Administration after receiving a “refusal-to-file” letter, which means the FDA isn’t going to review the company’s advanced-stage ...

During the first year of the Trump administration, signs of an anti-mRNA slant within the FDA and the Department of Health and Human Services (HHS) became more and more evident. | The FDA specifically ...

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.

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 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 ...

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

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

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