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.
A 7/2023 inspection of Eli Lillys Branchburg, NJ cites eight GMP deficiencies, according to inspection documents referenced in a Reuters report.
Federal Register notice: FDA announces a 3/5 Medical Imaging Drugs Advisory Committee meeting to review and discuss a Lumicell NDA for pegulicianine f...
FDA approves MRI labeling on Abbotts dorsal root ganglion (DRG) stimulation therapy, the Proclaim DRG neurostimulation system.
FDA accepts for review a Novocure PMA that seeks approval for the use of tumor treating fields therapy together with standard systemic therapies for t...
FDA and CMS officials call for support of an FDA proposal to regulate laboratory-developed tests.
