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

Science reported that the National Institutes of Health (NIH) director, Jay Bhattacharya, dismissed all members of the agency’s top external advisory body, the Advisory Committee to the Director (ACD) ...

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

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 vaccine is the first to receive full approval for use in children aged 6 months to 11 years with a high-risk health issue.

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

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

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.

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 ...

Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. | In this tracker, Fierce Pharma is recording the ...

The FDA has approved new versions of Pfizer/BioNTech's Comirnaty and Moderna's Spikevax COVID-19 vaccines that target the Omicron KP.2 strain of SARS-CoV-2 which was dominant in the US in recent ...