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 ...

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

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

The anti-science, anti-medicine mindset of the nutso Health and Human Services Secretary Robert F. Kennedy Jr. is killing people by quashing life-saving vaccines. There is no other explanation why ...

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

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

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

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 ...

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

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

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