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...
Federal Register notice: FDA announces a 3/5 Medical Imaging Drugs Advisory Committee meeting to review and discuss a Lumicell NDA for pegulicianine f...
A 7/2023 inspection of Eli Lillys Branchburg, NJ cites eight GMP deficiencies, according to inspection documents referenced in a Reuters report.
Globus Medical recalls its ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit due to a calibration error.
FDA adds a Boxed Warning to Amgens osteoporosis drug Prolia (denosumab) about increased risk of severe hypocalcemia in patients with advanced chronic ...
