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FDA Approves Hemlibra (emicizumab-kxwh) for Hemophilia A with Inhibitors

November 16, 2017 — The U.S. Food and Drug Administration today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called… Read More..

November 16th, 2017

FDA Approves Mepsevii (vestronidase alfa) for Mucopolysaccharidosis Type VII

November 15, 2017 — The U.S. Food and Drug Administration today approved Mepsevii (vestronidase alfa-vjbk) to treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as… Read More..

November 15th, 2017

FDA Approves Fasenra (benralizumab) for Severe Eosinophilic Asthma

November 14, 2017 — AstraZeneca (NYSE:AZN) and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has approved Fasenra (benralizumab) for the add-on maintenance treatment of… Read More..

November 13th, 2017

Allergan Receives FDA Approval for Vraylar (cariprazine) in the Maintenance Treatment of Schizophrenia

DUBLIN, Nov. 13, 2017 /PRNewswire/ — Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for the maintenance treatment of… Read More..

November 12th, 2017

FDA Approves Abilify MyCite (aripiprazole) Pill with Sensor to Digitally Track if Patients Have Ingested Their Medication

November 13, 2017 — The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that… Read More..

November 12th, 2017
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