The decision applies to adolescents and adults and aligns with earlier US authorization for higher-risk groups.

The FDA will reportedly add a “black box” warning to Covid-19 vaccines as the Trump administration steps up its attack on ...

Amid a period of contention, the largest study of its kind, published by researchers in France, suggests a surprising effect ...

Moderna and other vaccine stocks tumbled Monday after an FDA director reportedly issued a memo that says Covid shots killed ...

In July, the FDA updated the warning label for the Pfizer and Moderna Covid vaccines to warn that the risk of myocarditis and pericarditis, inflammation of the membranes surrounding the heart, was ...

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

An expert panel of the EU drug regulator, the European Medicines Agency (EMA), endorsed seven new medicines for approval this ...

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.

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people ...

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

The FDA probe is more extensive than previously understood, as it encompasses both adult and pediatric cases. "FDA is doing a thorough investigation, across multiple age groups, of deaths potentially ...

The US Food and Drug Administration intends to put a ‘black box’ warning on COVID-19 vaccines, CNN reported on Friday, citing ...