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 ...

Jaqueline Corrigan-Curay, who serves as acting head of the FDA’s Center for Drug Evaluation and Research, will depart next ...

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

The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump ...

The reported dismissal of high-ranking CBER officials Nicole Verdun and Rachael Anatol resurfaced lingering concerns about ...

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 ouster of the FDA's chief regulator of cell and gene therapies came immediately after a disagreement with her boss over a ...

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.