Tag Archives: Approves

FDA Approves Secuado (asenapine) Transdermal System for the Treatment of Adults with Schizophrenia

FDA Approves Secuado (asenapine) Transdermal System for the Treatment of Adults with Schizophrenia Print this page Miami, FL And Jersey City, NJ, October 15, 2019 — Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced the U.S. Food and Drug Administration (FDA) has approved Secuado (asenapine) transdermal system, the first-and-only transdermal patch… Read More »

FDA Approves Label Update for Crysvita (burosumab) for the Treatment of X-Linked Hypophosphatemia (XLH) in Pediatric Patients 6 Months of Age and Older

Print this page NOVATO, Calif., and TOKYO, Sept. 30, 2019 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare diseases, and Kyowa Kirin Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Crysvita (burosumab). The label has been updated to include… Read More »

FDA Approves Nourianz (istradefylline) as an Add-On Drug to Treat Off Episodes in Adults with Parkinson’s Disease

FDA Approves Nourianz (istradefylline) as an Add-On Drug to Treat Off Episodes in Adults with Parkinson’s Disease Print this page TOKYO–(BUSINESS WIRE)– August 28, 2019 — Kyowa Kirin Co., Ltd., (Kyowa Kirin, TYO: 4151) announces today that the U.S. Food and Drug Administration (FDA) has granted approval for Nourianz (istradefylline) for use as adjunctive treatment… Read More »

FDA approves new treatment for refractory multiple myeloma

Today, the U.S. Food and Drug Administration granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two… Read More »