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 ...

Moderna stock has faced heavy pressure from negative headlines, regulatory setbacks and political uncertainty. See why I ...

Arboviruses are spreading beyond tropical and subtropical regions owing to climate change, population growth, and increased ...

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 vaccine Spikevax in children aged six months through 11 years who are at ...

He cited similar safety concerns in a May 30 document, entitled “override memo,” regarding wide recommended use of Moderna’s latest version of its mRNA vaccine, mNexspike.

Those limits match the terms FDA recently approved for Novavax’s shot, Nuvaxovid and Moderna’s mNexspike.

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.

A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...