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FDA issues Gilead Sciences a complete response letter on its NDA for lenacapavir, an investigational, long-acting HIV-1 capsid inh...[ Price : $8.95]
FDA issues three safety alerts warning users to not use three Covid-19 tests because they could generate false results.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Patient-Focused Drug Development: Methods To Identify What ...[ Price : $8.95]
Lexicon Pharmaceuticals voluntarily withdraws its NDA for sotagliflozin, indicated for reducing the risk of cardiovascular death, ...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of an Elanco new animal drug application for use of a prolonged-release bolus cont...[ Price : $8.95]
Arnall Golden Gregory partner Alan Minsk predicts that CDER Office of Prescription Drug Promotion staff this year are likely to fo...[ Price : $8.95]
FDA officials on a bioresearch monitoring Webinar offer good clinical practice recommendations to sponsors and clinical trial site...[ Price : $8.95]
FDA sends a letter to healthcare professionals that emphasizes the importance of lifelong surveillance of patients with abdominal ...