Fresenius Medical Care recalls some of its 2008 Series Hemodialysis Machines because patients may be exposed to toxic compounds that leach from some p...
FDA sends Sanofi and Regeneron a complete response letter on their supplemental BLA for Dupixent (dupilumab) and its use in chronic spontaneous urtica...
FDA posts a Medtronic notice warning healthcare professionals about stolen defective McGrath MAC video laryngoscopes that have been offered for sale i...
FDA posts a revised draft guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of ...
FDA sets the rates and payment procedures for fiscal year 2024 generic new animal drug program user fees.
Federal Register notice: FDA announces the rates and payment procedures for fiscal year 2024 animal drug user fees.
FDA approves a Celltrion BLA for Zymfentra (infliximab-dyyb) for maintenance therapy in adults with moderately to severely active ulcerative colitis a...
FDA issues Panacea Biotec Pharma a nine-item Form FDA-483 after inspecting the firms Himachal Pradesh, India manufacturing 10/3-12.
