George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and ...

Federal officials say the FDA is reviewing reports of possible deaths in adults and children following COVID-19 vaccination.

The FDA's Vinay Prasad recently claimed in an internal memo that at least 10 children have died from coronavirus vaccines, ...

The FDA recently claimed that the COVID-19 vaccine was responsible for the death of 10 children. A physician discusses the ...

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 is reportedly preparing to place a serious “black box” warning on COVID-19 vaccines, ...

Investing.com -- The U.S. Department of Health and Human Services on Friday refuted earlier CNN claims that the FDA was considering adding a "black box" warning to Covid-19 vaccines.

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 ...

A black box warning is the strongest caution for prescription drugs and is usually reserved for alerting patients to possible ...

Doctors say the complication is normally mild and eases on its own without treatment. In severe cases, however, it can cause ...

The plan, which is expected to be unveiled before the end of the year, has not been finalized and may still change, CNN ...

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 ...