Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in ...

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.

In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...

Moderna's Spikevax vaccine has been fully approved for children with high-risk conditions, the first vaccine to do so.

Moderna, Inc. (MRNA) on Thursday announced that the U.S. Food and Drug Administration (FDA) has fully approved its COVID-19 ...

The full approval of Spikevax covers children aged six months through 11 years who are at increased risk for severe COVID-19, transitioning the vaccine from emergency use to full licensure.

Spikevax is now approved for all adults aged 65 years and older, and individuals aged 6 months through 64 years at increased risk for COVID-19 disease ...

The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

Fresh off of the heels of a shakeup at the CDC over vaccine recommendations, many Americans still question the necessity and ...

The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...