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.
Covis asks FDA to determine that Eugia should have filed a 505(b)(2) NDA rather than an ANDA for its proposed generic form of Covis Makena Autoinjecto...