FDA posts a draft guidance to assist NDA sponsors in properly submitting patent information for listing in the agency's Orange Book.
Jazz Pharmaceuticals says its Phase 3 LAGOON study evaluating Zepzelca (lurbinectedin) in relapsed small cell lung cancer failed to meet its primary e...
Some 17 Senate Democrats write to HHS secretary Robert F. Kennedy Jr., questioning many of his personnel decisions and expressing concern about the na...
Takeda says its investigational TYK2 inhibitor zasocitinib performed significantly better than Bristol Myers Squibbs Sotyktu in a Phase 3 head-to-head...
FDA cautions Port Jervis Laboratories in Port Jervis, NY, about CGMP violations in its manufacturing of over-the-counter drugs.
CDRH associate director for compliance and quality Keisha Thomas tells the RAPS Quality Conference about FDAs new Quality Management System Regulation...
A new Congressional Research Service report outlines FDAs evolving approach to regulating artificial intelligence-enabled medical devices and reviews ...
FDA issues an early alert regarding a potentially high-risk issue affecting certain patient circuits used with Baxter's Volara System.
