FDA clears a RapidAI 510(k) for the Rapid LVO for detecting suspected large vessel occlusions.
FDA clears Deep Blue Medical Advances T-Line hernia mesh.
FDA accepts a Novartis supplemental BLA for a new self-administration option for Xolair (omalizumab).
FDA accepts a TG Therapeutics NDA for umbralisib, a once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon for treating certain patients with ...
Federal Register notice: FDA announces a10/30 public workshop entitled New Drugs Regulatory Program Modernization: Implementation of the Integrated As...
FDA makes available a draft guidance entitled Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment.
FDA makes available a draft guidance entitled Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment.
FDA approves NS Pharmas Viltepso to treat Duchenne muscular dystrophy patients with a specific confirmed gene mutation.