Federal Register notice: FDA makes available a final guidance entitled Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Tre...
Federal Register notice: FDA seeks comments on an information collection revision for Orphan Drugs; 21 CFR Part 316.
FDA classifies as Class 1 a recall of Becton Dickinsons Alaris Pump Module and Pump Module Door Assembly Replacement Kits because the keypad may have ...
Federal Register notice: FDA makes available a draft guidance entitled Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment.
FDA updates its information Web page about eligibility for its Voluntary Malfunction Summary Reporting program.
FDA issues Mesoblast a complete response letter on its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease...
Federal Register notice: FDA makes available a draft guidance entitled Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment.
FDA approves Bristol-Myers Squibbs Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for first-line treatment of adults with malignant pleura...