Tag Archives: approves

FDA Approves Baqsimi (glucagon) Nasal Powder for the Treatment of Severe Hypoglycemia

FDA Approves Baqsimi (glucagon) Nasal Powder for the Treatment of Severe Hypoglycemia Print this page July 24, 2019 — The U.S. Food and Drug Administration today approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection. Severe hypoglycemia occurs when a patient’s… Read More »

FDA Approves Zolgensma (onasemnogene abeparvovec-xioi) Gene Therapy to Treat Pediatric Patients with Spinal Muscular Atrophy

FDA Approves Zolgensma (onasemnogene abeparvovec-xioi) Gene Therapy to Treat Pediatric Patients with Spinal Muscular Atrophy Print this page May 24, 2019 — The U.S. Food and Drug Administration today approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe… Read More »

FDA Approves Piqray (alpelisib) as First PI3K Inhibitor for Breast Cancer

FDA Approves Piqray (alpelisib) as First PI3K Inhibitor for Breast Cancer Print this page May 24, 2019 — Today, the U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2… Read More »