The FDA is reportedly considering the addition of high-level warning labels to COVID vaccines, a move that some experts say ...

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

Sources speaking exclusively to CNN say the U.S. Food & Drug Administration intends to place its most serious safety label, a ...

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

The agency claimed that 10 children’s deaths were linked to the shots, although it did not release evidence to support the ...

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

“FDA is doing a thorough investigation, across multiple age groups, of deaths potentially related to coronavirus vaccines,” ...

Moderna ​reiterated its previous statement that there were no new or undisclosed safety concerns in children or in pregnant ...

A new study identifies a mechanism for how COVID vaccines may, in infrequent cases, drive heart inflammation, a condition ...

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

CNN’s Meg Tirrell reports on the US Food and Drug Administration’s plans to add a “black box” warning to Covid-19 vaccines, ...