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 ...

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna ...

Senior FDA official Vinay Prasad reportedly overrode his staff in deciding to reject Moderna's application for a new seasonal flu shot.

The Food and Drug Administration has refused to review an application from the biotech company Moderna to approve its mRNA-based flu vaccine. The agency’s decision, which Moderna announced in a press ...

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

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

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

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

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