The U.S. Food and Drug Administration (FDA) recently informed Moderna that it would not review the company’s application for approval of its new flu vaccine, which is its first using mRNA technology ...

Moderna said it met with the FDA on Tuesday to discuss the vaccine and afterward, the U.S. regulator accepted a revised ...

Moderna’s messenger RNA influenza vaccine succeeded in two pivotal clinical trials, but the Food and Drug Administration is refusing to even review the application seeking regulatory approval, telling ...

Feb 13 (Reuters) - Moderna said it is looking for growth overseas after the U.S. FDA refused to review its experimental flu shot and the country's top health officials have deprioritized vaccination.

The Food and Drug Administration said it would review vaccine maker Moderna's application for a new kind of flu shot after the company agreed to further study it in older people. (Bill Sikes | AP) The ...

The European Medicines Agency (EMA) announced Friday it has recommended Moderna’s combined mRNA COVID-19 and flu vaccine be ...

Feb 18 (Reuters) - (This is an excerpt of the Health Rounds newsletter, where we present latest medical studies on Tuesdays and Thursdays. To receive the full newsletter in your inbox for free sign up ...

Feb 18 (Reuters) - Moderna said on Wednesday the U.S. drug regulator will review its modified flu vaccine application, a week after rejecting the original submission and fueling industry ‌concerns ...

The Food and Drug Administration rattled the biotech industry last week when it said it wouldn't even look at Moderna's application to market the first mRNA flu shot. But on Wednesday, the agency ...