The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna ...

By Stephanie Brown HealthDay ReporterTUESDAY, June 3, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...

A Phase III trial demonstrated mNEXSPIKE’s non-inferior efficacy compared with Moderna’s original COVID vaccine, Spikevax.

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

The FDA expanded its approval of Moderna's RSV vaccine on Thursday to include adults under age 60 at increased risk of the ...

FDA approves Moderna’s mNEXSPIKE COVID-19 vaccine for high-risk groups Phase 3 trial shows mNEXSPIKE outperforms original ...

Approval was based on data from the Phase III NextCOVE trial, which demonstrated that mNEXSPIKE met non-inferiority criteria ...

Expanded indication builds on existing U.S. FDA approval of mRESVIA for adults aged 60 and older CAMBRIDGE, MA / ACCESS ...

Moderna announced this weekend that the Food and Drug Administration approved its lower-dose Covid-19 vaccine for adults 65 and older, as well as people ages 12 to 64 with at least one medical ...

Jefferies analysts said the approval was largely expected and an “incremental positive” for Moderna amid questions about the ...

The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement ...

The FDA approved Moderna’s lower-dose COVID-19 vaccine, but only for individuals aged 65 years or older and people aged 12 to ...