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.

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.

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 ...

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

The FDA action comes weeks after US Health Secretary Robert F. Kennedy Jr said the government would no longer recommend the COVID vaccine for healthy children or pregnant people.

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

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

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

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

The approval of Moderna's Spikevax for kids at higher risk of contracting the disease continues the company's regulatory ...