Tag Archives: Approves

FDA Approves Nulibry (fosdenopterin) to Reduce the Risk of Mortality in Patients with Molybdenum Cofactor Deficiency (MoCD) Type A

FDA Approves Nulibry (fosdenopterin) to Reduce the Risk of Mortality in Patients with Molybdenum Cofactor Deficiency (MoCD) Type A PALO ALTO, February 28, 2021 – BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio) and affiliate Origin Biosciences, Inc. (Origin) today announced the U.S. Food and Drug Administration (FDA) has approved Nulibry (fosdenopterin) for Injection as the first… Read More »

FDA Approves Amondys 45 (casimersen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 45

FDA Approves Amondys 45 (casimersen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 45 CAMBRIDGE, Mass., Feb. 25, 2021 (GLOBE NEWSWIRE) — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Amondys… Read More »

FDA Approves Detectnet (copper Cu 64 dotatate injection) Positron Emission Tomography (PET) Agent

FDA Approves Detectnet (copper Cu 64 dotatate injection) Positron Emission Tomography (PET) Agent Print this page Houston, TX and St. Louis, MO, Sept. 08, 2020 (GLOBE NEWSWIRE) — RadioMedix Inc. and its commercial partner Curium announced today that Detectnet (copper Cu 64 dotatate injection) was approved by the U.S. Food and Drug Administration (FDA). Detectnet… Read More »

FDA Approves Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the Treatment of Asthma

Print this page London UK 9 September 2020 — GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) announced the US Food and Drug Administration (FDA) has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to… Read More »