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

The FDA is investigating deaths potentially related to COVID-19 vaccines across multiple age groups as part of a safety ...

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.

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

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 put a “black box” warning on Covid-19 vaccines, according to two people ...

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

There is underreporting of adverse effects from vaccines; but, in the vast majority of cases, the side effects from the ...

An array of under-the-radar initiatives are taking hold across the US, often tied to immunization, fluoridation and raw milk ...

The FDA is planning its strongest safety alert for Covid-19 vaccines as debates over risks, including myocarditis in young ...