Tag Archives: Approves

FDA Approves Accrufer (ferric maltol) for the Treatment of Iron Deficiency in Adults

FDA Approves Accrufer (ferric maltol) for the Treatment of Iron Deficiency in Adults Print this page London, UK, 26 July 2019: Shield Therapeutics plc (LSE: STX), a commercial stage, pharmaceutical company with a focus on addressing iron deficiency, announces that the U.S. Food and Drug Administration (FDA) has approved its lead product Accrufer® (Feraccru® in… Read More »

FDA Approves Keytruda (pembrolizumab) for First-Line Treatment of Head and Neck Squamous Cell Carcinoma

Print this page KENILWORTH, N.J.–(BUSINESS WIRE) June 11, 2019 –Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) or in combination with platinum… Read More »

FDA Approves Broadened Indication for Xeomin (incobotulinumtoxinA) as First-Line Treatment for Blepharospasm (Involuntary Blinking) in Adult Patients

Print this page RALEIGH, N.C.  –  May 13,  2019  –  Merz Americas announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA), broadening its indication to be a first-line treatment of blepharospasm (involuntary blinking) in adult patients. “Merz is proud to offer a first-line… Read More »