Federal Register notice: FDA makes available a final guidance entitled Patient-Focused Drug Development: Methods To Identify What Is Important to Pati...
Lexicon Pharmaceuticals voluntarily withdraws its NDA for sotagliflozin, indicated for reducing the risk of cardiovascular death, hospitalization for ...
Federal Register notice: FDA withdraws approval of an Elanco new animal drug application for use of a prolonged-release bolus containing sulfamethazin...
Arnall Golden Gregory partner Alan Minsk predicts that CDER Office of Prescription Drug Promotion staff this year are likely to focus on materials dis...
FDA officials on a bioresearch monitoring Webinar offer good clinical practice recommendations to sponsors and clinical trial site operators to avoid ...
FDA sends a letter to healthcare professionals that emphasizes the importance of lifelong surveillance of patients with abdominal aortic aneurysm endo...
FDA extends by three months its review of an AbbVie supplemental BLA for Skyrizi (risankizumab-rzaa) for treating moderate to severe Crohns disease.