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

Shares of Moderna rose Wednesday after the Food and Drug Administration reversed its earlier refusal and agreed to review the ...

At issue with Moderna's mRNA flu shot is communication from CBER to Moderna suggesting that the company’s vaccine be compared ...

Moderna said its new flu shot has been cleared for review in Australia, Canada and the European Union. It has asked to meet with the FDA. In May, the U.S. Department of Health and Human Services (HHS) ...

(The Hill) — Moderna announced Thursday it will receive up to $54.3 million from a global vaccine partnership to fund its ongoing research into a potential bird flu mRNA vaccine, helping to recover ...

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

Just last week, the agency rejected Moderna’s initial application, citing flaws in the company’s research design.

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

(This is an excerpt of the Health Rounds newsletter, where we present latest medical studies on Tuesdays and Thursdays.) Feb ...

US drug regulator originally refused to consider application, fueling critics’ concern about alleged ‘anti-vaccine agenda’ ...