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 ...

FDA approved mNEXSPIKE for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor, in late May. Moderna expects to have mNEXSPIKE ...

The Senate Health, Education, Labor and Pensions Committee yesterday voted to advance a vote on President Donald Trump's ...

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

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 ...

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.

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.

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 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.