The elimination of 3,500 full-time employees at the FDA risks undermining the very innovation and domestic capacity the ...

By Diana Novak Jones (Reuters) -A federal judge has rejected a bid by compounding pharmacies to allow them to continue making ...

Leaders of the FDA have published a list of new priorities for the agency. They want to deliver rapidly-approved cures and "unleash AI." ...

KalVista Pharmaceuticals' said on Friday that the U.S. Food and Drug Administration had extended the review of its drug for a ...

JB Chemicals has received US FDA approval to market its generic version of Amitriptyline Hydrochloride tablets, used to treat ...

The US Food and Drug Administration (FDA) has approved lenacapavir, an injectable drug that offers long-lasting protection ...

Agency’s new road map aims for faster approvals and healthier food, but some experts caution AI is not yet up to the task.

The FDA plans to "unleash AI" on new drug evaluations in order to "radically increase efficiency in the review process." ...

INCHEON, Korea & JERSEY CITY, N.J., May 27, 2025--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has ...

But there are limits. Some FDA staff said Elsa often gave wrong answers and has to be double-checked. Others said the tool ...

The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences lenacapavir, a twice-yearly injection, for ...