FDA releases three final cancer clinical trial guidances that officials say track with President Bidens renewed Cancer Moonshot.
FDA issues Gilead Sciences a complete response letter on its NDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor for treating ...
FDA issues three safety alerts warning users to not use three Covid-19 tests because they could generate false results.
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 ...