Moderna said its new flu shot has been cleared for review in Australia, Canada and the European Union. It has asked to meet ...

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

A U.S. Food and Drug Administration official on Wednesday defended the agency's surprise decision to not review Moderna's ...

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

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

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

Moderna said the move is inconsistent with previous feedback from the FDA on the experimental influenza shot, called ...

The head of the agency’s vaccine division, Vinay Prasad, has overruled pushback from career staffers.

The company said the agency wouldn’t review its application on the grounds that the study testing the shot wasn’t sufficient.

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

Signed Memorandum of Understanding supports "Plan Mexico," Mexico's strategic initiative to build a local mRNA ecosystem and ...

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