Federal Register notice: FDA withdraws approval of five Bacitracin for injection ANDAs from multiple holders Akorn, Mylan, Pfizer, XGen Pharmaceutica...
FDA alerts health care providers and laboratory staff about false positive results which can occur with the Roche Molecular Systems cobas SARS-CoV-2 a...
Combat Medical Systems recalls its Valkyrie LTOWB Collection, Valkyrie LTOWB Administration, Low Titer Type O FWB Transfusion Set, Fresh Whole Blood T...
FDA accepts for review a Marius Pharmaceuticals NDA for Kyzatrex (oral testosterone undecanoate) for primary and secondary male hypogonadism.
AstraZeneca plans to seek an emergency use authorization for its Covid-19 vaccine by early April after determining that it has met FDA data requiremen...
FDA clears a Baxter International 510(k) for its next-generation Artificial Kidney 98 (AK 98) dialysis machine, which is designed to be a portable sys...
Boehringer Ingelheim discontinues a Phase 2 trial of a first-in-class compound for reducing the risk or severity of acute respiratory distress syndrom...
FDA acting commissioner Janet Woodcock discusses two lessons learned about clinical research from the Covid-19 pandemic.