Tag Archives: Approves

FDA Approves Accrufer (ferric maltol) for the Treatment of Iron Deficiency in Adults

FDA Approves Accrufer (ferric maltol) for the Treatment of Iron Deficiency in Adults Print this page London, UK, 26 July 2019: Shield Therapeutics plc (LSE: STX), a commercial stage, pharmaceutical company with a focus on addressing iron deficiency, announces that the U.S. Food and Drug Administration (FDA) has approved its lead product Accrufer® (Feraccru® in… Read More »

FDA Approves Xpovio (selinexor) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

FDA Approves Xpovio (selinexor) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma Print this page NEWTON, Mass., July 03, 2019 (GLOBE NEWSWIRE) — Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an oncology-focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved oral Xpovio (selinexor), a nuclear export inhibitor, in combination… Read More »

FDA Approves Nayzilam (midazolam) Nasal Spray to Treat Seizure Clusters

FDA Approves Nayzilam (midazolam) Nasal Spray to Treat Seizure Clusters Print this page Brussels (Belgium) & Atlanta, Georgia (U.S.) – May 20 2019: UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application for the company’s newest anti-epileptic drug (AED) Nayzilam (midazolam) nasal spray CIV, a benzodiazepine indicated… Read More »

FDA approves expanded label for Regeneron/Sanofi’s cholesterol drug

(Reuters) – The U.S. Food and Drug Administration on Friday approved Regeneron Pharmaceuticals Inc’s cholesterol drug Praluent as a treatment to cut the risk of heart attacks, stroke and other major cardiovascular events. The FDA’s decision will allow the drug, developed along with Sanofi SA, to be prescribed to reduce the overall risk of major… Read More »

FDA Approves Jatenzo (testosterone undecanoate) for Certain Forms of Hypogonadism

FDA Approves Jatenzo (testosterone undecanoate) for Certain Forms of Hypogonadism Print this page March 27, 2019 — The U.S. Food and Drug Administration today approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. These men have low testosterone levels due to specific medical conditions, such as genetic disorders… Read More »