By Siddhi Mahatole and Puyaan Singh July 7 (Reuters) - The U.S. Food and Drug Administration said on Tuesday it had approved ...

A record-high number of Americans say they have tried a weight-loss drug, a new national poll from Gallup found. The survey ...

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...

How did staff layoffs, inspection backlogs and unprecedented leadership turnover affect the ability of the FDA to approve new drugs in 2025? While it would be presumptuous to base conclusions solely ...

The U.S. Food and Drug Administration (FDA) announced Wednesday that it will relax certain rules for approving low-cost versions of some high-priced medications, in an effort to speed up access to ...

By Bhanvi Satija and Sriparna Roy June 17 (Reuters) - The U.S. FDA has approved GSK's oral antibiotic to treat complicated urinary tract infections, the regulator said on Wednesday, giving patients a ...

FDA enforcement will focus on restricting GLP-1 APIs in mass-marketed, nonapproved compounded products to address unverifiable quality, safety, and efficacy under the FD&C Act. Appropriate compounding ...

The Food and Drug Administration on Thursday selected nine drugs for expedited reviews intended to speed up the approval process. Why it matters: The awarding of the new priority review vouchers is a ...

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. with a fresh draft guidance proposing more changes to streamline development of the cheaper biologic copies.

A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved under the U.S. Food and Drug Administration's "Breakthrough Therapy ...

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...