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

The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...

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

Moderna's COVID-19 vaccine has received full approval from the U.S. Food and Drug Administration (FDA) for use in children ...

The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally ...

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

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

The Food and Drug Administration (FDA) granted full approval on Thursday to Moderna’s COVID-19 vaccine for children, making it the first COVID shot for kids aged 6 months to 11 years old that is ...

The FDA this week fully approved Moderna’s COVID-19 vaccine for children aged 6 months to 11 years but limited the approval ...

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.

FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...

The government’s top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval of two COVID-19 vaccines, disregarding recommendations from government ...