FDA approves an Eli Lilly supplemental NDA for a label update for Taltz (ixekizumab) injection 80 mg/mL to include data in psoriasis involving the gen...
FDA issues a complete response letter recommending an additional Phase 3 trial of Cosmo Pharmaceuticals Methylene Blue MMX coloring agent.
FDA accepts for review a Sanofi NDA for Zynquista (sotagliflozin), an oral treatment added to insulin therapy to improve blood sugar control in adults...
FDA clears a Synedgen 510(k) for its Catasyn Advanced Technology Wound Hydrogel for use under the direction of a health care professional and over-the...
Federal Register notice: FDA announces a 6/26 joint advisory committee meeting to review a Pain Therapeutics NDA for a proposed abuse-deterrent oxycod...
FDA warns Chinas Nox Bellow Cosmetics about CGMP violations in its production of finished pharmaceuticals.
FDA warns Cerno Pharmaceuticals about CGMP and misbranding violations in its production of finished drugs.
FDA posts a seven-item Form 483 following a 5/1 inspection of Biocons Bangalore, India drug substance and drug product manufacturing facility.