Cambridge: Moderna has received approval from the U.S. Food and Drug Administration (FDA) for the supplemental Biologics ...

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

In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...

Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in ...

Moderna's Spikevax vaccine has been fully approved for children with high-risk conditions, the first vaccine to do so.

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

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

US FDA approves Moderna’s Covid-19 vaccine, Spikevax in children aged 6 months through 11 years at increased risk for Covid-19 disease: Cambridge, Massachusetts Saturday, July 1 ...

The company’s breakthrough success with its COVID-19 vaccine, Spikevax, catapulted it into the global spotlight and validated its technological platform.

The FDA has updated labels on the top two COVID-19 vaccines to warn of a rare heart side effect, mostly seen in young men. Here's what to know.