A fter just a few controversial months, Vinay Prasad, MD, MPH, has stepped down as director of FDA's Center for Biologics Evaluation and Research (CBER).

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

The mNEXSPIKE approval marks Moderna’s third FDA-approved product, giving them a heftier commercial portfolio than many investors give them credit for.

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) Nucleoside ...

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.

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.