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 ...

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

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

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

The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with mRNA ...

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

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

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

By Rashika Singh Feb 11 (Reuters) - Shares of Moderna slumped nearly 9% in premarket trading on Wednesday after the U.S. Food ...

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

CNBC's Kelly Evans reports on the latest news.