The vaccine maker’s shots involve the successful Covid vaccines’ RNA technology. Health Secretary Robert F. Kennedy Jr. has ...

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 refused to review Moderna’s application for its new mRNA flu vaccine — a move the pharma ...

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

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 ...

The US FDA has refused to review Moderna’s mRNA flu vaccine application, citing concerns over its clinical trial comparator.

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 ...

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

Moderna stock is rated Sell amid FDA setbacks for mRNA-1010, commoditized COVID/RSV sales, and cash burn. Read the analysis ...

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 ...