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 ...

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 ...

Those limits match the terms FDA recently approved for Novavax’s shot, Nuvaxovid and Moderna’s mNexspike. Novavax’s vaccine is the only protein-based coronavirus vaccine available in the U.S ...

FDA staff reached a similar conclusion for the Moderna vaccine, deeming it similar in safety and effectiveness to the company’s original shot.