The Food and Drug Administration (FDA) is investigating whether the COVID-19 vaccines were associated with any deaths across ...

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.

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

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

Federal officials say the U.S. Food and Drug Administration (FDA) is reviewing reports of possible deaths in adults and ...

An anti-vaccine organization founded by HHS Secretary Robert F. Kennedy Jr. is urging the FDA he now oversees to pull the licenses of Pfizer's and Moderna's COVID-19 vaccines.

"FDA is doing a thorough investigation, across multiple age groups, of deaths potentially related to COVID vaccines," HHS ...

The label is the strictest safety warning issued by the FDA, alerting healthcare providers and patients about serious or life-threatening adverse side effects.

FDA turns up the heat: Federal regulators are requesting more safety information from drugmakers on products meant to protect ...

The inquiry was spearheaded by FDA official Vinay Prasad, an anti-vaxxer who has cited little evidence for his claims.

The U.S. health regulator is investigating deaths potentially related to COVID-19 vaccines across multiple age groups as part ...

HHS on Monday appointed biostatistician and epidemiologist Martin Kulldorff, PhD, a critic of U.S. COVID-19 vaccine policy, ...