The U.S. Food and Drug Administration has granted full approval for Moderna's MRNA.O COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years who are at an increased risk of the disease, ...

Moderna MRNA announced that the FDA has approved its supplemental biologics license application seeking approval for COVID-19 ...

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 ...

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.

Photo: Adobe Stock Despite the CDC’s move to kick the COVID-19 vaccine off recommended immunization schedules for children ...

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

Fresh off of the heels of a shakeup at the CDC over vaccine recommendations, many Americans still question the necessity and ...

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

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

On June 25, the FDA released a report announcing updated requirements in mRNA COVID-19 vaccine warning labels for Comirnaty by Pfizer Inc. and Spikevax by ModernaTX Inc. Prescribing information ...