The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu ...

The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel ...

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

Moderna took the unusual step of announcing the FDA’s refusal and releasing the agency’s letter. The letter states that Moderna did not conduct an “adequate and well-controlled” study because it had ...

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 Food and Drug Administration on Wednesday defended its rejection of Moderna’s mRNA-based flu vaccine application, saying the company’s clinical trial design put patients at risk ...

The US pharma firm’s 40,000-person study suggested its new shot was more effective than a standard flu vaccine.

Moderna said its new flu shot has been cleared for review in Australia, Canada and the European Union. It has asked to meet with the FDA. In May, the U.S. Department of Health and Human Services (HHS) ...

Moderna’s mRNA influenza vaccine faces US regulatory delays after a refusal-to-file letter from top FDA official Dr Vinay Prasad.

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 ...

FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying it contradicts prior FDA guidance.

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