Moderna will not commit to previous 2028 breakeven guidance as the ripple effects of the FDA’s refusal-to-file decision spread through its pipeline.

Experts say ‘they’re just coming up with reasons’ as agency says application lacked ‘adequate and well controlled’ trial ...

Mani Foroohar, M.D., of Leerink Partners, says that the decision reflects “how sharp the departure has been between the prior ...

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 ...

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 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 ...

Learn about the safety and effectiveness of COVID-19 vaccines for kids, the possible side effects, and the benefits of vaccination.

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

HHS Spokesman Andrew Nixon told The National News Desk via email that the FDA rejected Moderna’s application for filing because “the company refused to follow very clear FDA guidance from 2024 to test ...

The US Food and Drug Administration's (FDA’s) Center for Biologics Evaluation and Research (CBER) is refusing to review Moderna’s application for approval of a new flu vaccine. The decision comes ...

Regulators move the goalposts for a manufacturer that uses mRNA technology.

The new shot was not compared to “the best-available standard of care in the United States at the time of the study,” an FDA ...