FDA announces that former Flatiron Health chief medical officer Amy Abernethy will replace retiring Rachel Sherman as the agencys principal deputy com...
Torrent Pharmaceuticals expands an earlier recall from two lots of hypertension drug losartan potassium tablets USP to a total of 10 lots due to the d...
FDA accepts a Nabriva Therapeutics NDA and granted a priority review for Contepo (fosfomycin for injection) to treat complicated urinary tract infecti...
Endologix says it is discontinuing unrestricted sales of its Nellix stent graft for treating abdominal aortic aneurysms and limiting its use to pre-sc...
Verrica Pharmaceuticals says it is planning an NDA submission in the second half of the year for VP-102 for treating molluscum contagiosum, a highly c...
Akonni Biosystems files a 510(k) to market the TruDiagnosis system, its proprietary microarray-based technology.
FDA and the American Society for Clinical Pharmacology and Therapeutics co-sponsor a 3/13 conference on PBPK Modeling for the Development and Approval...
FDA approves a StemCyte IND to conduct a Phase 2 trial of its Allogeneic Human Leukocyte Antigen-Matched Umbilical Cord Blood Mononuclear Stem Cells f...