FDA posts a draft guidance entitled Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices.
FDA accepts for priority review a Genentech supplemental BLA for Xolair (omalizumab) for reducing allergic reactions, including anaphylaxis, that may ...
FDA grants Bone Health Technologies a de novo marketing authorization for its Osteoboost, the first non-pharmacological device-based prescription trea...
Gilead Sciences says its Trodelvy Phase 3 EVOKE-01 study did not meet its primary endpoint of overall survival in previously treated patients with met...
FDA clears a Kallisio 510(k) for Stentra, a 3D-printed oral stent designed to protect healthy tissue in head and neck cancer patients.
Federal Register notice: FDA seeks comments on an information collection extension entitled Prescription Drug Marketing: Administrative Procedures, Po...
Federal Register notice: FDA announces that Abbvies Qulipta was approved using a material threat medical countermeasure priority review voucher.
Federal Register notice: FDA announces a 2/13 meeting of its Medical Devices Advisory Committees Circulatory System Devices Panel that will vote on an...
