Biogen releases data it says demonstrate the long-term value of its Aduhelm as an Alzheimers disease treatment.
Members of the House and Senate say PhRMA provided them with misleading information about the role of drug manufacturers in January drug price increas...
Federal Register notice: FDA announces the fee rates under the over-the-counter monograph drug user fee program for fiscal year 2022.
FDA approves an AbbVie supplemental NDA for Rinvoq (upadacitinib) for treating certain adults with moderately to severely active ulcerative colitis.
FDA warns Glendale, CA-based Accu Bio-Chem Laboratories about CGMP violations in its work as a contract testing laboratory.
Federal Register notice: FDA permanently debars Nayade Varona from providing services to anyone having an approved or pending drug product application...
Federal Register notice: FDA seeks comments on an information collection extension entitled Agreement for Shipment of Devices for Sterilization 21 CF...
FDA warns Bishop, CA-based NeuroField about Quality System and other violations in its manufacturing of neurostimulation and electroencephalogram sign...