FDA accepts for priority review an Albireo Pharma NDA for odevixibat for treating pruritus in patients with progressive familial intrahepatic cholesta...
FDA approves an Aurinia Pharmaceuticals NDA for Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adu...
FDA Review posts the Federal Register notices for the week ending 1/22/2021.
FDA approves a Boston Scientific PMA for its fourth-generation Vercise Genus Deep Brain Stimulation System.
A Sidley law briefing examines HHSs unprecedented overreach during the Trump Administration, which has drawn increased interest in making FDA an indep...
FDA approves an Exelixis NDA for Cabometyx (cabozantinib) in combination with Bristol Myers-Squibbs Opdivo (nivolumab) for treating patients with adva...
FDA gives the green light to Ultragenyx Pharmaceutical to begin a seamless single-protocol Phase 1/2/3 study of UX701, an investigational AAV9 gene th...