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

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.

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

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

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

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 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 ...

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 company also recently received FDA approval for its new Covid-19 vaccine mNEXSPIKE. To mitigate the price decline and loss of revenue, the company has shifted to focus on cost efficiencies, as ...

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 ...