By Mariam Sunny and Michael Erman Feb 13 (Reuters) - Moderna said it is looking for growth overseas after the U.S. FDA ...

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

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

Presented by the Coalition to Strengthen America’s Healthcare{beacon} Health Care Health Care The Big Story FDA refuses ...

Moderna will report its fourth-quarter 2025 earnings this morning in an investor call that’s taken on even more interest in ...

By Mariam Sunny and Michael Erman Feb 11 (Reuters) - A U.S. Food and Drug Administration official on Wednesday defended the ...

Moderna received a refusal-to-file letter from the FDA objecting to how it conducted a 40,000-person trial comparing its new ...

Vinay Prasad, the Trump administration’s top vaccine regulator at the Food and Drug Administration, single-handedly decided ...

Drug observers puzzled by vaccine maker, which made a killing on COVID-19, failing to read the room with new administration. Moderna puts heat on FDA vaccines chief who's already been rebuked once by ...

The Food and Drug Administration refused to review Moderna’s application for its new mRNA flu vaccine — a move the pharma ...

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

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