The move makes Moderna’s vaccine, called Spikevax, the first COVID shot for kids in the U.S. to be fully approved, rather ...

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.

The U.S. Food and Drug Administration has granted full approval for Moderna's MRNA.O COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years who are at an increased risk of the disease, ...

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

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

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

The FDA this week fully approved Moderna’s COVID-19 vaccine for children aged 6 months to 11 years but limited the approval ...

The Food and Drug Administration July 10 approved Moderna’s Spikevax COVID-19 vaccine for children under 12 with at least one ...

Moderna stock jumps 4.5% as the FDA grants full approval for its COVID-19 vaccine in high-risk individuals aged six months to ...

The U.S. Food and Drug Administration approved "Spikevax," Moderna's vaccine for children aged 6 months to 11 years old. The ...

The US Food and Drug Administration (FDA) has approved US mRNA specialist Moderna supplemental Biologics License Application ...