FDA approves a Roche PMA for its fourth-generation HIV combination antigen-antibody assay, the Elecsys HIV combi PT assay.
Federal Register notice: FDA announces a 9/11 public meeting on Patient-Focused Drug Development for Alopecia Areata.
Federal Register notice: CDRH seeks nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device pa...
FDA approves a Portola Pharma NDA for Bevyxxa (betrixaban) for preventing venous thromboembolism in adult patients hospitalized for an acute medical i...
Federal Register notice: FDA withdraws approval of 121 NDAs and 161 ANDAs from multiple applicants.
Federal Register notice: FDA announces a 7/18 public meeting on The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.
FDA grants Zogenix an orphan drug designation for its investigational drug, ZX008 (low-dose fenfluramine), for treating Lennox Gastaut Syndrome.
CDER Office of Surveillance acting director Sarah Pope Miksinski says that starting early next year, FDA begins a voluntary drug quality metrics repor...