Tag Archives: Approves

FDA Approves Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea

FDA Approves Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea Print this page DUBLIN, March 20, 2019 /PRNewswire/ — Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) approved Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive… Read More »

FDA Approves Gloperba (colchicine) for Prophylaxis of Adult Gout Flares

FDA Approves Gloperba (colchicine) for Prophylaxis of Adult Gout Flares Print this page WOBURN, Mass.–(BUSINESS WIRE)–February 26, 2019 ROMEG Therapeutics, an innovative drug development company focused on alternative formulations to better meet clinical and patient needs, today announced that the U.S. Food and Drug Administration (FDA) approved Gloperba (colchicine) Oral Solution, 0.6 mg/5 mL for… Read More »

FDA Approves Darzalex (daratumumab) Split-Dosing Regimen

Print this page Horsham, PA, February 12, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a split-dosing regimen for Darzalex® (daratumumab), providing healthcare professionals and patients with multiple myeloma an option to split the first infusion over two consecutive days.[1] The… Read More »