Moderna noted the FDA did not identify any specific safety concerns with the vaccine and that the rejection was inconsistent ...

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

The Food and Drug Administration rejected Moderna's new flu shot. This raises questions about what it means for the future of vaccine development.

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 FDA rejected Moderna's application for filing because the company refused to follow very clear FDA guidance from 2024 to ...

Moderna Inc. lashed out at the US Food and Drug Administration for making it harder for companies to create new medicines, ...

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

The head of the agency’s vaccine division, Vinay Prasad, has overruled pushback from career staffers.

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

At issue with Moderna's mRNA flu shot is communication from CBER to Moderna suggesting that the company’s vaccine be compared ...

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 ...

Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA ...