FDA posts a revised guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Stea...
Medtronic recalls its HawkOne Directional Atherectomy System due to the risk of the guidewire within the catheter moving downward or prolapsing when f...
FDA lifts a partial clinical hold on a Kura Oncology Phase 1b study (KOMET-001) of KO-539 in patients with relapsed or refractory acute myeloid leukem...
FDA Oncology Center of Excellence director Richard Pazdur suggests changes to the agencys accelerated approval program, such as international harmoniz...
FDA grants Arch Oncology an orphan drug designation for AO-176 and its use in treating relapsed/refractory multiple myeloma.
FDA issues Pfizer and OPKO Health a complete response letter for their BLA for somatrogon, an investigational once-weekly long-acting recombinant huma...
Federal Register notice: FDA seeks comments on its proposal to classify human leukocyte antigen, human platelet antigen, and human neutrophil antigen ...
Federal Register notice: FDA classifies retinal diagnostic software devices into Class 2 (special controls).