FDA posts a final guidance entitled Institutional Review Board (IRB) Written Procedures that is intended to harmonize FDA and HHS Office for Human Res...
Boehringer Ingelheim plans to submit an NDA for nerandomilast for treating progressive pulmonary fibrosis following its release of positive data from ...
FDA clears an Ibex Medical Analytics 510(k) for the Ibex Prostate Detect, an in vitro diagnostic that uses artificial intelligence to generate heatmap...
FDA grants Tempest Therapeutics a fast track designation for amezalpat (TPST-1120) for treating patients with hepatocellular carcinoma.
Roche shares with FDA positive data from the Phase 3 REGENCY trial of Gazyva (obinutuzumab) in people with active lupus nephritis.
Senators Dick Durbin (D-IL) and Roger Marshall (R-KS) call on FDA to take enforcement action against a planned direct-to-consumer commercial that will...
FDA clears a RapidAI 510(k) for its Lumina 3D, an automated 3D imaging reconstruction device designed to replace manual workflows.
FDA grants Adicet Bio a fast-track designation for ADI-001 and its use in treating adult patients with refractory systemic lupus erythematosus with ex...
