Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based ...

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

Vaccine maker Moderna announced today that the US Food and Drug Administration (FDA) has granted full approval of its ...

Yet only small percentages of patients with new diagnoses sought follow-up care, started or completed treatment, or attained ...

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.

Moderna, Inc. (MRNA) on Thursday announced that the U.S. Food and Drug Administration (FDA) has fully approved its COVID-19 ...

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

The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots.

The new vaccine (mNexspike [COVID-19 Vaccine, mRNA]) represents a significant step forward in the development of next-generation coronavirus vaccines, the Associated Press reported.

MRNA wins FDA approval for mNexspike, a fridge-stable COVID shot, but with a narrower use label than it sought.