FDA issues an Early Alert for a Baxter Spectrum infusion pump software issue.
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FDA issues a draft guidance entitled Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and L...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.
A new FDA report examines the demographic representation of clinical trials supporting the approval of 50 novel drug therapies last year.
