Outset Medical says it will cooperate with FDA in an effort to resolve a 7/5 Warning Letter about its Tablo Hemodialysis System.
Sarepta Therapeutics sells for $102 million its Rare Pediatric Disease Priority Review Voucher that was awarded last month.
FDA issues Hemogenyx Pharmaceuticals a clinical hold on an IND for the companys chimeric antigen receptor T-cells therapy for treating acute myeloid l...
New York University researchers say more study is needed to develop uniform marketing guidelines for software-heavy medical devices that match their 5...
FDA grants Theriva Biologics an orphan drug designation for VCN-01, a systemic, selective, stroma-degrading oncolytic adenovirus for treating pancreat...
Madrigal Pharmaceuticals begins a rolling NDA submission seeking accelerated approval of resmetirom for treating nonalcoholic steatohepatitis.
Teleflex recalls its Slick Set Uncuffed Endotracheal Tube and Stylet Set (oral/nasal) due to reports about the 15mm connector disconnecting from the e...
Bipartisan House members reintroduce the Promising Pathway Act that would provide a provisional approval pathway for promising drugs.
