The FDA plans to put a 'black box' warning on Covid-19 vaccines, alarming experts who say there is no basis for the warning.

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

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, ...

An anti-vaccine organization founded by HHS Secretary Robert F. Kennedy Jr. is urging the FDA he now oversees to pull the ...

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

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

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

The FDA is reportedly preparing to add what's known as a "black box" warning to Covid shots by the end of the year, marking a ...

The U.S. Food and Drug Administration intends to put a “black box” warning on COVID-19 vaccines, CNN reported today, citing two people familiar with the agency’s plans.