FDA seeks information and comments about how it plans to administer generic drug program fees beginning in fiscal year 2018 (10/1).
FDA extends by three months the user fee review date for a Roche BLA for Ocrevus (ocrelizumab), indicated for treating patients with relapsing forms o...
FDA lifts a full clinical hold on CTI BioPharmas pacritinib for treating myelofibrosis.
An analysis from McDermott Will & Emory says drug and biologics developers may benefit from a provision in the recently signed 21st Century Cures Act ...
FDA grants a Roche de novo request to allow the marketing of its Anti-Mllerian (AMH) assay, what the company calls the first approved fully automated ...
FDA cancels a 2/16-planned Psychopharmacologic Drugs Advisory Committee meeting to review a Neurocrine Biosciences NDA for Ingrezza (valbenazine) for ...
Federal Register Final Order: FDA reclassifiew surgical instrumentation for use with urogynecologic surgical mesh from Class 1 (general controls) exem...
FDA accepts for review an Ironwood Pharmaceuticals NDA for Duzallo (fixed-dose combination of lesinurad and allopurinol) for treating hyperuricemia in...