FDA orders Limitation of Use wording in labeling for extended-release stimulants used to treat ADHD to raise the risk of weight loss in children under...
FDA issues a draft guidance entitled Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and L...
Consultant Erika Roberts says FDAs rollout of its staff AI tool Elsa is a good first step, but much more needs to be done to reach the potential of us...
FDA approves a Sirtex Medical PMA for its SIR-Spheres Y-90 resin microspheres for treating unresectable hepatocellular carcinoma.
A group of medical societies files suit against HHS secretary Robert F. Kennedy Jr. and FDA commissioner Marty Makary to reverse a 5/27 decision to re...
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 7.
FDA clears an Atmo Biosciences 510(k) for the ingestible Atmo Gas Capsule System for assessing both whole and regional gut transit times.
A new FDA report examines the demographic representation of clinical trials supporting the approval of 50 novel drug therapies last year.
