The US pharma firm’s 40,000-person study suggested its new shot was more effective than a standard flu vaccine.

(Reuters) -Moderna said on Friday it has filed a marketing application for the review of its updated COVID-19 vaccine with the U.S. Food and Drug Administration. The company said the submission for ...

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

Moderna, Inc. (NASDAQ:MRNA) today announced that it had voluntarily withdrawn the pending Biologics License Application (BLA) seeking approval for its COVID-19 and Influenza combination vaccine for ...

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 ...