FDA clears a Surmodics 510(k) for its Pounce LP (Low Profile) Thrombectomy System.
Federal Register notice: FDA makes available a final guidance entitled Content of Premarket Submissions for Device Software Functions.
The CDER Biomarker Qualification Program says it supports four pancreatic injury microRNA biomarkers identified and evaluated by the C-Path Predictive...
Two Sheppard Mullin attorneys describe FDAs latest effort to improve written patient-facing drug safety and efficacy information.
2seventy bio says its Seattle Childrens partner has paused a Phase 1 pediatric acute myeloid leukemia trial following a patient fatality.
FDA approves an Amneal Pharmaceuticals 505(b)(2) for Pemrydi RTU, a ready-to-use version of pemetrexed for injection.
FDA gives Starton Therapeutics the green light to proceed with a Phase 1b clinical trial of its Star-LLD investigational continuous delivery lenalidom...
NeuroOne Medical Technologies files a 510(k) for its OneRF Ablation System.
