FDA says Pfizer is expanding its Chantix recall and Apotex can temporarily distribute some of its generic Chantix product in the U.S. with levels of a...
A Business Group on Health study group recommends changes to the pharmaceutical supply chain system to counter government drug pricing regulations.
FDA clears a First Light Diagnostics 510(k) for its SensiTox C. difficile toxin test along with its proprietary MultiPath Analyzer.
FDA announces a class-wide labeling change for cholesterol-lowering statin drugs to remove its strongest warning against their use in pregnant patient...
FDA denies a petition asking it to withdraw approval of Osakas Jynarque for treating autosomal dominant polycystic kidney disease.
FDA grants NeuroMetrix a breakthrough designation for its Quell device and its use in treating the symptoms of fibromyalgia in adults.
Ortho Regenerative Technologies says it has submitted information requested by FDA to resolve a clinical hold on the Ortho-R drug/biologic combination...
FDA acting commissioner Janet Woodcock says that beginning this month, FDA started transitioning back to standard operations for domestic inspections.