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

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

Moderna stock has faced heavy pressure from negative headlines, regulatory setbacks and political uncertainty. See why I ...

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

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

Cambridge: Moderna has received approval from the U.S. Food and Drug Administration (FDA) for the supplemental Biologics ...

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 ...

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S. that will no longer be administered under an emergency use authorization.

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

Moderna's Spikevax receives FDA approval for use in high-risk children; Pfizer, BioNTech appeal U.K. ruling in COVID-19 ...

FDA-approved Spikevax has the same formulation as the Moderna COVID-19 vaccine that was previously authorized for emergency use in the U.S.