Federal Register notice: FDA announces a 10/8 joint advisory committee meeting to review an Arbor Pharmaceuticals NDA for a drug to treat attention de...
Federal Register notice: FDA issues Nippon Shinyaku a priority review voucher after approval of its rare disease drug Viltepso (viltolarsen), indicate...
FDA posts a final guidance entitled Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testin...
FDA accepts an Ascendis Pharma BLA for its TransCon hGH (lonapegsomatropin), an investigational long-acting prodrug of somatropin (human growth hormon...
FDA grants Project ALS an orphan drug designation for prosetin and its use in treating amyotrophic lateral sclerosis.
Federal Register notice: FDA announces an 11/9 device panel meeting that will review a Refocus Group PMA for the VisAbility Micro Insert, an implant f...
Federal Register notice: FDA makes available a final guidance entitled Control of Nitrosamine Impurities in Human Drugs.
FDA reminds healthcare providers of the advisability of conducting a trial stimulation period in patients before implanting a spinal cord stimulator.