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 rejected Moderna’s application for its mRNA-based flu vaccine, the drugmaker said Tuesday ...

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

FDA issues a surprise refusal to review Moderna's mRNA-based flu vaccine filing, despite earlier agreement on trial design.

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.

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 ...

Drug observers puzzled by vaccine maker, which made a killing on COVID-19, failing to read the room with new administration. Moderna puts heat on FDA vaccines chief who's already been rebuked once by ...

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 ...