Federal Register notice: FDA announces a 2/13 meeting of its Medical Devices Advisory Committees Circulatory System Devices Panel that will vote on an...
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 ...
Senator Amy Klobuchar (D-MN) sends letters to six pharmaceutical companies Abbvie, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Mylan-Viatris,...
FDA approves a Janssen Biotech NDA for Balversa (erdafitinib) for treating certain adult patients with locally advanced or metastatic urothelial carci...
An FDA reinspection of Alvotechs Iceland manufacturing facility results in a Form FDA-483 with one inspection finding.
Federal Register notice: FDA announces a 3/5 Medical Imaging Drugs Advisory Committee meeting to review and discuss a Lumicell NDA for pegulicianine f...
