In a major blow to vaccine development, the FDA said it will not review Moderna’s application for the first mRNA-based flu shot.

Moderna Inc.’s shares fell after US regulators refused to review its novel mRNA flu vaccine, creating regulatory chaos for ...

By Mariam Sunny and Michael Erman Feb 13 (Reuters) - Moderna said it is looking for growth overseas after the U.S. 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 FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.

On Feb. 10, pharmaceutical company Moderna announced that the FDA Center for Biologics Evaluation and Research (CBER) had refused to review its application to market an investigational mRNA-based flu ...

Moderna’s mRNA-1010 was expected to contribute $1 billion to the company’s coffers by 2028. That plan is now out the window after the FDA refused to even look at the application.

I wouldn’t go so far as to categorize the pandemic as the “good old days,” but during the 2020-2021 flu season, only 1,316 positive flu cases were reported in the U.S. Why? Because most of us were ...