FDA grants Breakthrough Therapy designation to Janssens erdafitinib for treating advanced urothelial cancer in adults.
FDA clears a Royal Philips 510(k) for is ProxiDiagnost N90, a digital radiography-fluoroscopy system.
FDA gives 510(k) clearance to DxNow for its ZyMot ICSI and ZyMot Multi Sperm Separation devices.
FDA places a Solid Biosciences IGNITE DMD clinical trial for Duchenne Muscular Dystrophy on hold.
FDA says its tests show that glutamine in a United Pharmacy glutamine, arginine, and carnitine product degraded before its expiration date.
A Public Citizen report says that federal criminal penalties against drug companies have fallen precipitously.
FDA warns Opternative that it is distributing a mobile medical device app without agency approval.
Federal Register correction notice: FDA corrects a final order entitled Medical Devices; Hematology and Pathology Devices; Classification of Lynch Syn...