Human Drugs
Equillium Gets Fast Track for Itolizumab
FDA grants Equillium a fast track designation for itolizumab for treating lupus nephritis.
FDA General
Latest Federal Register Notices
FDA Review has posted the Federal Register notices for the week ending 12/6/2019.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Joint Panel to Review Nektar Back Pain Drug
Federal Register notice: FDA announces a 1/14/2020 Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advis...
Federal Register
Review Period for Biomarins Palynziq
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Biomarin Pharmaceuticals Palynziq (pegvaliase-p...
Human Drugs
Draft Guide on Corticosteroid Products for Hemorrhoids
FDA releases a draft guidance entitled Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with...
Medical Devices
Magnetic Resonance Coil Performance Criteria Guide
FDA posts a draft guidance on Magnetic Resonance (MR) Coil Performance Criteria for Safety and Performance Based Pathway.
Human Drugs
Amgens Remicade Biosimilar Gains Approval
FDA approves an Amgen BLA for Avsola (infliximab-axxq), a biosimilar of Janssens Remicade, indicated for treating Crohns disease, ulcerative colitis, ...
Biologics
Increased Enforcement on Violative Cell/Tissue Products
FDA steps up its enforcement efforts against violative cell/tissue products, and issues warnings against Liveyon Labs on the heels of similar actions ...
Human Drugs
Physician Convicted in Insy Therapeutics Scheme
A federal court convicts New York physician Gordon Freedman for participating in a scheme to receive bribes and kickbacks through sham educational pro...
