FDA sets a 6/22 PDUFA action date for an Amylyx NDA for its Alzheimers investigational drug.
FDA clears Bioventus neXus bone scalpel handpiece.
FDA issues a guidance with recommendations on non-clinical and clinical studies for medical devices to treat benign prostatic hyperplasia.
FDA approves fast track designation for an acute myeloid leukemia indication for Celularitys CYNK-001 cell therapy.
FDA approves Novartis Cosentyx to treat two forms of arthritis in some pediatric and adult patients.
FDA grants fast track designation for BioArctic and Eisais early Alzheimers drug lecanemab.
FDA approves Novartis Leqvio to lower cholesterol in specified high-risk adults.
Federal Register notice: FDA seeks comments on whether it should grant an exclusive patent license to Houston, TX-based Voxel Systems for the governme...