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 ...

Rep. Marjorie Taylor Greene slams FDA green lighting of Moderna's mNEXSPIKE COVID-19 vaccine, describing the move as "Not ...

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

The Food and Drug Administration expanded the approval of Moderna’s RSV vaccine on Thursday, extending the license to include ...

NEXSPIKE becomes Moderna’s third FDA-approved product CAMBRIDGE, MA / ACCESS Newswire / May 31, 2025 / Moderna, Inc.

MRNA wins FDA approval for mNexspike, a fridge-stable COVID shot, but with a narrower use label than it sought.

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

FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.

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

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 vaccine, named mNexspike, is part of a push toward next-generation coronavirus protection. Moderna says the new formula ...

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 ...