The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...

U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines ...

U.S health officials are updating the prescribing labels of long-acting ADHD medications to carry new warnings for children ...

Writing in JAMA, four former government officials warn that the Trump administration’s involvement in delaying the approval ...

Makary and Center for Biologics Evaluation and Research Director Vinay Prasad unveiled a new framework in the New England ...

The generic drug contains cefovecin sodium, the same active ingredient in Convenia (Zoetis Inc), which was approved by the ...

Curay, the top FDA drug regulator, acknowledged that much is still in flux at the agency and introduced a new deputy.

She wrote that she decided to leave the agency after taking a recent vacation, and thanked staff for their “unwavering support, especially during recent challenging times.” Corrigan-Curay will remain ...

Capricor Therapeutics said on Tuesday the U.S. Food and Drug Administration may not seek its outside experts' advice when ...

At the start of an unprecedented meeting of vaccine committee of the US Centers for Disease Control and Prevention, the ...