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

The decision, which shocked company officials, comes as the FDA says it will take a stricter approach to federal vaccine ...

Moderna received what’s called a “refusal-to-file” letter from the FDA that objected to how the company conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu ...

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 ...

Moderna said its new flu shot has been cleared for review in Australia, Canada and the European Union. It has asked to meet ...

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

Moderna shares sink 10% after FDA issues Refusal-to-File letter for its mRNA-1010 flu vaccine, citing trial design concerns ...

The Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with mRNA technology, the company said.

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 ...

In a news release late Tuesday, Moderna said it was blindsided by the FDA’s refusal, which the FDA cited as being due to the design of the company’s Phase 3 trial for its mRNA flu vaccine, dubbed mRNA ...