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

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

The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine, mRNA-1010. The company said the agency’s justification for refusing a review is inconsistent with ...

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 ...

It's conspicuous that HHS refuses to review Moderna's application for regulatory approval of an mRNA-based flu vaccine while it prioritizes research on debunked theories.

HHS Spokesman Andrew Nixon told The National News Desk via email that the FDA rejected Moderna’s application for filing ...

FDA Defends Flu Vaccine Decision ...

This week, vaccine manufacturer Moderna revealed that Vinaya Prasad, the top vaccine regulator at the Food and Drug ...

The Food and Drug Administration has refused to review an application from the biotech company Moderna to approve its mRNA-based flu vaccine. The agency’s decision, which Moderna announced in a press ...

The Food and Drug Administration on Wednesday defended its rejection of Moderna’s mRNA-based flu vaccine application, saying ...

Senior FDA official Vinay Prasad reportedly overrode his staff in deciding to reject Moderna's application for a new seasonal flu shot.

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