Three stakeholders comment on an FDA draft guidance on using registries to support drug and biological product regulatory decision-making as part of r...
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...