Tag Archives: Approval

Chiesi Global Rare Diseases Announces FDA Approval of Ferriprox (deferiprone) for Treatment of Transfusional Iron Overload due to Sickle Cell Disease

May 1, 2021 Approval is based on demonstrated reduction in liver iron concentration Expanded indications for patients with sickle cell disease or other anemias, as well as thalassemia – BOSTON, May 1, 2021 /PRNewswire/ — Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today… Read More »

Jazz Pharmaceuticals Announces FDA Approval of Additional Indication for Vyxeos (daunorubicin and cytarabine) for the Treatment of Secondary Acute Myeloid Leukemia in Pediatric Patients

DUBLIN, March 30, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved a revised label for Vyxeos® (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients aged one year and older. The approval of Vyxeos for this indication… Read More »

Roche’s new approval Enspryng cuts relapse risk in NMOSD—and provides extended benefits

Squaring off against Alexion and AstraZeneca spinoff Viela Bio with a new treatment in neuromyelitis optica spectrum disorder (NMSOD), Roche is touting new data analyses for its Enspryng that show a dramatic reduction in the risk of severe relapses, plus benefits of extended treatment.  In an analysis of two previously published Phase 3 studies comprising 178 NMOSD patients, those who received Enspryng saw a 79% lower risk… Read More »