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

The approval of Moderna's Spikevax for kids at higher risk of contracting the disease continues the company's regulatory ...

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

Key Takeaways The U.S. Food and Drug Administration gave full approval to Moderna’s COVID shot for kids ages 6 months to 11 ...

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

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 ...

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

FDA grants full approval to Moderna's COVID-19 vaccine for children aged 6 months to 11 years with medical vulnerabilities, ...

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 ...

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 ...

The FDA published a database of letters sent to drugmakers during the review process of medications that provide information on the agency's initial feedback or requirements for more data. These ...