Tag Archives: Pediatric

FDA Approves Koselugo (selumetinib) for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas

FDA Approves Koselugo (selumetinib) for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas Print this page 13 April 2020 — AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the US Food and Drug Administration (FDA) has approved the kinase inhibitor Koselugo… 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 »