The full approval of Spikevax covers children aged six months through 11 years who are at increased risk for severe COVID-19, transitioning the vaccine from emergency use to full licensure.

The US Food and Drug Administration (FDA) has approved US mRNA specialist Moderna supplemental Biologics License Application ...

Shares of biotechnology company Moderna (NASDAQ:MRNA) jumped 3.8% in the morning session after the U.S. Food and Drug ...

US regulators have fully approved Moderna's Spikevax COVID-19 vaccine for children aged 6 months to 11 years, but only for ...

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 ...

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

Vaccine maker Moderna announced today that the US Food and Drug Administration (FDA) has granted full approval of its ...

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

Pfizer and its German partner BioNTech asked London's Court of Appeal on Thursday to overturn a ruling that their COVID-19 ...

The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

Moderna (MRNA) stock rises as the company's Spikevax COVID-19 vaccine gets FDA approval for kids 6 months-11 years at higher ...

The label expansion for Moderna’s jab arrives at a juncture in America’s changing vaccine regulatory landscape.