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

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

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

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

The flu vaccine is its first using mRNA technology for influenza.

Moderna said on Tuesday that the Food and Drug Administration (FDA) has refused to review its application for an mRNA flu ...

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

Federal officials on Wednesday cast blame on Moderna as they stood by the Food and Drug Administration’s controversial ...

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

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

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

The move is further in line with HHS Secretary Kennedy's anti-vaccine policies ...