Tag Archives: announces

Lupin Announces FDA Approval of Supplemental New Drug Application for Solosec (secnidazole) for the Treatment of Trichomoniasis

BALTIMORE, July 1, 2021 /PRNewswire/ –Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of global pharma major Lupin Limited (Lupin), announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental New Drug Application (sNDA) to expand the use of Solosec (secnidazole) to include the treatment of trichomoniasis in adults. Trichomoniasis… Read More »

Vertex Announces U.S. FDA Approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages 6 through 11 With Certain Mutations

BOSTON–(BUSINESS WIRE)–Jun. 9, 2021– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages 6 through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a… Read More »

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 »