The company announced the FDA’s full approval in a statement July 10, noting its COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under emergency use authorization.

Moderna's COVID-19 vaccine has received full approval from the U.S. Food and Drug Administration (FDA) for use in children with medical conditions that put them at higher risk of severe illness.

The Food and Drug Administration (FDA) granted full approval on Thursday to Moderna’s COVID-19 vaccine for children, making it the first COVID shot for kids aged 6 months to 11 years old that is ...

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

Stoboclo and Osenvelt, FDA-approved biosimilars of Prolia and Xgeva, are now available in the U.S. for variois cancers and cancer-related bone conditions.

The FDA has approved its requested updated versions of expanded warning labels for COVID-19 vaccines. As Healio previously reported, the FDA sent letters to Moderna and Pfizer/BioNTech in April ...

Food and Drug Administration. FDA approves required updated warning in labeling of mRNA COVID-19 vaccines regarding myocarditis and pericarditis following vaccination. Posted on: June 25, 2025.

The Food and Drug Administration has approved Moderna’s next-generation mRNA COVID-19 vaccine mNexspike.

The product is a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years.

The Food and Drug Administration (FDA) has approved Moderna’s next-generation mRNA COVID-19 vaccine mNexspike ®. The new vaccine is indicated for active immunization to prevent COVID-19 caused ...

Moderna’s newest lower-dose COVID-19 vaccine is approved for all adults 65 and older, and for people aged 12 to 64 who are at higher risk from the disease.