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

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, ...

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

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

This stock used to be a highflyer but has struggled in recent years as demand waned for its flagship product. Though Moderna ...

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

The approval of Moderna's Spikevax for kids at higher risk of contracting the disease continues the company's regulatory winning streak, which has also included nods for a next-gen COVID-19 vaccine ...

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

The label expansion sought by GSK is a bid to compete with Pfizer and Moderna in the younger age groups of the RSV vaccine market. Pfizer’s Abrysvo and Moderna’s mRESVIA are both approved to prevent ...