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...
CDRH associate director for compliance and quality Keisha Thomas tells the RAPS Quality Conference about FDAs new Quality Management System Regulation...
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.
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.
