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 ...

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 ...

Dupixent (dupilumab) Interleukin-4 receptor alpha antagonist Treatment of adult patients with bullous pemphigoid. Dupixent Gains Approval for Bullous Pemphigoid mNexspike (COVID-19 vaccine ...

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.

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.

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.