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

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

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 ...

Pfizer (PFE) and BioNTech (BNTX) challenge Moderna's patent win in London court over mRNA COVID-19 vaccine technology. Read ...

Moderna’s mNEXSPIKE (mRNA-1283), a new COVID-19 vaccine, received FDA approval based on Phase III trial data showing higher relative vaccine efficacy than Spikevax. The vaccine will be available for ...