Tag Archives: Approves

FDA Approves Fotivda (tivozanib) for the Treatment of Adult Patients with Relapsed or Refractory Advanced Renal Cell Carcinoma

FDA Approves Fotivda (tivozanib) for the Treatment of Adult Patients with Relapsed or Refractory Advanced Renal Cell Carcinoma BOSTON–(BUSINESS WIRE) March 10, 2021 — AVEO Oncology (Nasdaq: AVEO) today announced that the U.S. Food and Drug Administration (FDA) has approved Fotivda (tivozanib) for the treatment of adults with relapsed or refractory advanced renal cell carcinoma… Read More »

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 Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

TARRYTOWN, N.Y., Oct. 14, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced today that the U.S. Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. “We are… Read More »

FDA Approves Alkindi Sprinkle (hydrocortisone oral granules) for Pediatric Adrenocortical Insufficiency

FDA Approves Alkindi Sprinkle (hydrocortisone oral granules) for Pediatric Adrenocortical Insufficiency DEER PARK, Ill., Sept. 29, 2020 (GLOBE NEWSWIRE) — Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Alkindi Sprinkle (hydrocortisone)… Read More »

FDA Approves Onureg (azacitidine tablets) as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia

FDA Approves Onureg (azacitidine tablets) as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia Print this page PRINCETON, N.J.–(BUSINESS WIRE) September 1, 2020 –Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult… Read More »