In its main clinical trial, mRNA-1010 was shown to be 26.6% more effective than the comparator flu shot in adults aged 50 ...

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

The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine, mRNA-1010. The company ...

The FDA has refused to review Moderna’s application for its messenger RNA-based influenza vaccine, according to the company.In a press release, Moderna noted that the FDA’s rejection of the vaccine, ...

Moderna (MRNA) stock fell 9% premarket after FDA rejected its flu vaccine application due to trial design issues, despite ...

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

The US recently overhauled its longstanding guidance on childhood immunisation and rolled back recommendations for routine ...

Moderna said the move is inconsistent with previous feedback from the FDA on the experimental influenza shot, called mRNA-1010.

The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.

The FDA said in its refusal letter that the company's approach to compare mRNA-1010 to an already licensed standard-dose ...

The Food and Drug Administration rejected Moderna’s application for its mRNA-based flu vaccine, the drugmaker said Tuesday ...

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