The FDA recently claimed that the COVID-19 vaccine was responsible for the death of 10 children. A physician discusses the ...

Vinay Prasad, director of the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), ...

With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to ...

Such warnings are reserved for medications that carry risks of death or life-threatening reactions.

The final Dec. 5 memo, according to FDA employees with knowledge of the situation, states that under an established World ...

The U.S. Food and Drug Administration intends to put a "black box" warning on COVID-19 vaccines, CNN reported on Friday, ...

The US Food and Drug Administration intends to add a “black box” warning to COVID-19 vaccines, according to two sources ...

This is precisely why open access to scholarly research is the antidote to challenge misinformation: it empowers citizens to ...

Vinay Prasad’s memo makes alarming claims about the COVID-19 vaccine — including the assertion, made without any supporting ...

The FDA intends to place a black box label—its most serious warning—on COVID-19 vaccines, according to reporting by CNN. It ...

The move towards a higher threshold for showing efficacy for new CAR-Ts comes after the FDA loosened the requirements for ...