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 ...

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. with a fresh draft guidance proposing more changes to streamline development of the cheaper biologic copies.

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 ...

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 ...

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 ...

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 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 looking to get thrifty with its approved drugs. Through a newly proposed repurposing initiative, the agency hopes to help address unmet medical needs by finding new uses for ...

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 ...

Share on Pinterest The FDA puts forward a move to exclude GLP-1 drugs from the bulk compounding list. Image credit: VICTOR TORRES/Stocksy On April 30, 2026, the U.S. FDA announced it is considering ...

The FDA announcement specifically mentions gene editing, although agency officials said the new approach could also be used by other drugs and therapies. It’s a shift long sought by patients, ...

Pavan Subramani started doing molecular dynamics simulations for computational drug discovery alongside his high school coursework, sparking an interest in a STEM career.