Tag Archives: Approves

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients PAOLI, Pa., — (BUSINESS WIRE) — November 9, 2020 – Sedor Pharmaceuticals, LLC (Sedor) today announced that the U.S. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult… Read More »

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis CARY, N.C., Nov. 02, 2020 (GLOBE NEWSWIRE) — Chiesi USA, Inc., the U.S. affiliate of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), received U.S. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Bronchitol… Read More »

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19 FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 22, 2020– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. As an antiviral drug, Veklury works to stop replication… Read More »

FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma

PRINCETON, N.J.–(BUSINESS WIRE) October 2, 2020 — Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with unresectable malignant pleural… Read More »