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

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

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

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

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

Moderna took the unusual step of announcing the FDA’s refusal and releasing the agency’s letter. The letter states that Moderna did not conduct an “adequate and well-controlled” study because it had ...

The vaccine maker’s shots involve the successful Covid vaccines’ RNA technology. Health Secretary Robert F. Kennedy Jr. has ...

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

By Sneha S K Feb 10 (Reuters) - The U.S. Food and Drug Administration will not review Moderna's approval application for its ...

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu ...

In an interview, Moderna President Stephen Hoge took questions on an FDA decision on the biotech's mRNA flu vaccine, as well ...

The F.D.A.’s refusal to examine the company’s mRNA shot drew widespread criticism from doctors and was divisive within the agency.