America’s drug safety agency declined to review a next-gen flu vaccine that uses the same tech as the coronavirus shots ...

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

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

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

By Mariam Sunny and Rashika Singh Feb 11 (Reuters) - Shares of Moderna slumped nearly 7% on Wednesday after U.S. regulators ...

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

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 ...

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

On Feb. 10, pharmaceutical company Moderna announced that the FDA Center for Biologics Evaluation and Research (CBER) had refused to review its application to market an investigational mRNA-based flu ...

Influenza vaccination is associated with significantly lower odds of myocardial infarction (MI), according to a large meta-analysis published late last week in BMC Public Health. In the study, ...

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 ...

The Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with mRNA technology, the company said.