OncBioMune Pharmaceuticals submits to FDA a Phase 2 clinical trial protocol for ProscaVax, a novel therapeutic cancer vaccine for early stage prostate...
FDA grants OncoSec Medical an orphan drug designation for ImmunoPulse IL-12 (tavokinogene telsaplasmid) for treating unresectable metastatic melanoma.
Federal Register notice: FDA determines that it is necessary for manufacturers of certain reusable medical devices to include in their premarket notif...
FDA approves a Teva Pharmaceuticals ANDA for the first generic copy of Gileads Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg)...
FDA publishes a list of reusable medical devices needing validated cleaning instructions.
Pathologist and microbiologist Diane Alame says the U.S. needs a much more effective medical device safety monitoring system.
Federal Register notice: CBER, National Institutes of Health and National Institute of Allergy and Infectious Diseases announce a 7/10 public workshop...
FDA publishes updated information on the process added by the 21st Century Cures Act for qualification of drug development tools.