George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and ...

How the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) determine whether a ...

How the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) determine whether a vaccine has ...

Federal officials say the FDA is reviewing reports of possible deaths in adults and children following COVID-19 vaccination.

The FDA's Vinay Prasad recently claimed in an internal memo that at least 10 children have died from coronavirus vaccines, ...

With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former ...

The Food and Drug Administration rolled out a rapid-fire series of moves this month that could reshape how Americans manage ...

Investing.com -- The U.S. Department of Health and Human Services on Friday refuted earlier CNN claims that the FDA was considering adding a "black box" warning to Covid-19 vaccines.

The FDA’s claims about COVID-19 vaccine deaths in children lack strong evidence and could restrict vaccine access. Learn why ...