FDA posts a Federal Register notice finalizing the withdrawal of Intercept Pharmaceuticals Ocaliva (obeticholic acid) from the U.S. market for treatin...
FDA issues a correction notice for NOxBOX Ltd.s NOxBOXi Nitric Oxide Delivery System after reports of dosing fluctuations when the device is used with...
FDA approves Mercks checkpoint inhibitor Keytruda (pembrolizumab) in combination with Astellas and Pfizers antibody drug conjugate Padcev as a periop...
FDA issues an untitled letter to SK Life Science, raising concerns over a direct-to-consumer television advertisement for its seizure medication Xcopr...
Politico reports that FDA commissioner Marty Makary and HHS secretary Robert F. Kennedy, Jr., are feuding over vaccine safety studies and staffing app...
FDA says the Medline 8/22 recall of three models of surgical convenience kits that were not sterilized is Class 1.
FDA approves Regeneron Pharmaceuticals Eylea HD (aflibercept 8 mg) for treating macular edema following retinal vein occlusion.
FDA accepts for review a Nuvalent NDA for zidesamtinib, a next-generation ROS1-selective tyrosine kinase inhibitor being developed for certain adults ...
