FDA accepts for review an Epizyme supplemental NDA seeking accelerated approval for Tazverik (tazemetostat for certain patients with relapsed or refra...
FDA accepts for review a FibroGen NDA for roxadustat for treating anemia associated with chronic kidney disease.
FDA says it expects the coronavirus outbreak will lead to medical product supply chain disruptions as it reaches out to manufacturers to identifying p...
Federal Register notice: FDA posts a final guidance entitled Peripheral Vascular Atherectomy Devices Premarket Notification Submissions.
Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representatives to serve as temp...
The White House Council of Economic Advisers says the U.S. has paid more than its fair share for drug development and innovation because other countri...
A research study advocates for greater use of pharmacogenomic information in prescription drug labeling to aid the development of precision medicine.
FDA accepts for priority review a Seattle Genetics NDA for tucatinib for use in combination with trastuzumab and capecitabine for treating certain pat...