Human Drugs
FDA Approves Biogens Alzheimers Drug
FDA grants accelerated approval for Biogens Aduhelm (aducanumab), the first drug since 2003 approved for treating Alzheimers.
Human Drugs
Medtronic Deep Brain Stimulator Lead Approved
FDA approves a Medtronic PMA for the SenSight Directional Lead System used for deep brain stimulation therapy.
Human Drugs
Ultomiris OKd for Pediatric Blood Disorder
FDA approves an Alexion Pharmaceuticals BLA for Ultomiris (ravulizumab-cwvz) injection and its use in treating patients aged one month and older with ...
Biologics
FDA Lifts Holds on Bluebird Bio Trials
FDA lifts clinical holds against Bluebird Bios Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies of LentiGlobin gene therapy for sickle cell disease. ...
Biologics
ProMetics Ryplazim Approved for Plasminogen Disorder
FDA approves a ProMetic Biotherapeutics BLA for Ryplazim (plasminogen, human-tmvh) for treating patients with plasminogen deficiency Type 1.
FDA General
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 6/4/2021.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Guide on Suspect/Illegitimate Product Definitions
Federal Register notice: FDA posts a draft guidance on drug supply chain definitions of suspect and illegitimate products.
Federal Register
Guide on Drug Supply Security Product Identifiers
Federal Register notice: FDA makes available a final guidance entitled Product Identifiers Under the Drug Supply Chain Security Act: Questions and Ans...
Federal Register
Supply Chain Security Act Implementation Guide
Federal Register notice: FDA makes available a final guide entitled Drug Supply Chain Security Act Implementation: Identification of Suspect Product a...
