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FDA posts a draft guidance entitled Pulmonary Tuberculosis (TB): Developing Drugs for Treatment.
FDA publishes a draft guidance defining the types of behaviors that FDA considers to be delaying, denying, or limiting an inspection, or refusing to p...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...
OMB approves seven information collections that include humanitarian-use devices, Right-to-Try Act reporting, and positron emission tomography drug GM...
