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.
FDA authorizes Felix Pharmaceuticals generic nitenpyram tablets to treat New World screwworm infestations in dogs and cats.
FDA sends a second complete response letter to Camurus regarding its NDA for Oclaiz (octreotide), an extended-release injection under review for the t...
The Department of Justice says a federal grand jury has indicted the co-owner of Floridas Pine Care Research Center and two staff members on charges t...
