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's existing vaccine. It found the new vaccine was safe and was at least as ...

NEXSPIKE becomes Moderna’s third FDA-approved product CAMBRIDGE, MA / ACCESS Newswire / May 31, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has ...

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

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 ...

Rep. Marjorie Taylor Greene, R-Ga., slammed the U.S. Food and Drug Administration's move to give the green light to Moderna's mNEXSPIKE COVID-19 vaccine. "Not MAHA at all!!!," the congresswoman ...

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 will be marketed under the brand name mNexspike. This approval aligns with the FDA’s updated guidance from last month, which emphasizes vaccinating high-risk populations. mNexspike ...

Approval was based on data from the Phase III NextCOVE trial, which demonstrated that mNEXSPIKE met non-inferiority criteria compared to the original Spikevax as a vaccine for COVID-19. The FDA has ...

CAMBRIDGE, MA / ACCESS Newswire / May 31, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283), a new vaccine ...

Moderna MRNA announced the FDA approval for mRNA-1283, its next-generation refrigerator-stable COVID-19 vaccine, though for a ...