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 ...

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

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.

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 ...

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

Labels for the Pfizer and Moderna shots, which already caution about myocarditis and pericarditis, will more strongly stress risks.

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

Moderna (NASDAQ: MRNA), the next-generation healthcare company most famous for developing the Spikevax coronavirus vaccine, was an uncharacteristically popular stock.

The SpikeVax case study Moderna’s SpikeVax vaccine is based on LNP-encapsulated nucleoside-modified mRNA encoding the full-length SARS-Cov-2 spike protein.

Moderna's new version of its COVID-19 vaccine, which targets two virus variants including Omicron, has outperformed the company's original Spikevax shot in a head-to-head clinical trial. mRNA-1273 ...