Tag Archives: approves

FDA Approves Fiasp (insulin aspart injection) for the Treatment of Children with Diabetes

Print this page PLAINSBORO, N.J., Jan. 6, 2020 /PRNewswire/ — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Fiasp (insulin aspart injection) 100 u/mL for use as a new mealtime insulin option for children with diabetes.1 Fiasp is the first and only fast-acting mealtime insulin injection that does not… Read More »

FDA Approves Caplyta (lumateperone) for the Treatment of Schizophrenia in Adults

FDA Approves Caplyta (lumateperone) for the Treatment of Schizophrenia in Adults Print this page NEW YORK, Dec. 23, 2019 (GLOBE NEWSWIRE) — Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that Caplyta (lumateperone) has been approved by the U.S. Food and Drug… Read More »

FDA Approves Dayvigo (lemborexant) for the Treatment of Insomnia in Adult Patients

FDA Approves Dayvigo (lemborexant) for the Treatment of Insomnia in Adult Patients Print this page December 23, 2019 — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced that the U.S. Food and Drug Administration (FDA) approved the new drug application for its in-house discovered and developed orexin receptor antagonist Dayvigo (lemborexant). Dayvigo… Read More »

FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parental Nutrition (TPN)

FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parental Nutrition (TPN) Print this page DUBLIN, Ireland, Dec. 16, 2019 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced today that the U.S. Food and Drug Administration (FDA) has approved Nouress (AV001), a cysteine hydrochloride injection, a critical drug for treating neonatal… Read More »

FDA Approves Xcopri (cenobamate) for the Treatment of Partial-Onset Seizures in Adults

FDA Approves Xcopri (cenobamate) for the Treatment of Partial-Onset Seizures in Adults Print this page PANGYO, South Korea and PARAMUS, N.J., Nov. 21, 2019 /PRNewswire/ — SK Biopharmaceuticals, Co., Ltd., an innovative global pharmaceutical company focused on developing and bringing treatments to market for central nervous system (CNS) disorders, and its U.S. subsidiary SK Life… Read More »