From Crohn disease to uncomplicated urinary tract infections and beyond, the FDA issued several high-impact drug approvals last month.

Two former FDA leaders look at Commissioner Marty Makary’s early stumbles — and lay out a list of priorities to protect both ...

The Food and Drug Administration on Thursday cleared a core component of a brain implant made by Precision Neuroscience, a ...

Eli Lilly and Co., the maker of Zepbound and Mounjaro, announced a successful Phase 3 trial for a once-daily GLP-1 pill for ...

A three-judge panel wrestled Thursday with Novartis AG’s challenge against the FDA over its approval of a generic version of ...

The FDA announced it will be reducing, refining and potentially replacing the animal testing requirement for the approval of ...

The agency is missing deadlines and not responding to biotech companies, forcing some to push back clinical trials.

Before that, he talked exclusively to CBS News Chicago. Chicago police said 24-year-old Luther Hopkins III, of Calumet City, ...

After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda ...

"As of Tuesday, April 1, we had responded to all of the FDA's information requests," Novavax said in the filing, adding it believes its vaccine is ready for approval. "As of today, we continue to wait ...

Politicians, parents and anti-tobacco groups want the FDA to do more to stamp out unauthorized vaping products that can appeal to teens, many of which are imported from China. Tobacco and vaping ...

The city has taken a knife to its bureaucratic red tape and approved hundreds more outdoor-dining-shed applications for the start of the al fresco season Tuesday, The Post has learned. About 80 ...