FDA clears a Providence Medical Technology Cavux Facet Fixation System (FFS) for spinal surgery patients requiring a revision for an anterior pseudart...
Dr. Reddys subsidiary Aurigene Oncology halts the development of its psoriasis investigational drug after reporting poor results of a placebo-controll...
FDA posts a draft guidance entitled Pulmonary Tuberculosis (TB): Developing Drugs for Treatment.
FDA publishes a draft guidance defining the types of behaviors that FDA considers to be delaying, denying, or limiting an inspection, or refusing to p...
Three Ropes & Gray attorneys describe the potential for a Circuit Courts of Appeals split over FDA authority in regulating stem cell clinics.
FDA publishes a revised guidance incorporating GDUFA 3 performance goals for complete response letter activities.
FDA extends by three months its review of an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) in combination with Janssens Zytiga (abira...