Tag Archives: Approves

FDA Approves Rezurock (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD)

FDA Approves Rezurock (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD) NEW YORK, NY / ACCESSWIRE / July 16, 2021 / Kadmon Holdings, Inc. (Nasdaq:KDMN) today announced that the U.S. Food and Drug Administration (FDA) has approved Rezurock™ (belumosudil) 200 mg once daily (QD) for the treatment of adult and pediatric patients… Read More »

FDA Approves Kerendia (finerenone) for the Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes

FDA Approves Kerendia (finerenone) for the Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes WHIPPANY, N.J.– July 9, 2021 (BUSINESS WIRE)– Bayer announced today the United States (U.S.) Food and Drug Administration (FDA) has approved Kerendia (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained… Read More »

FDA Approves Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

FDA Approves Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma DUBLIN, June 30, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic regimen for… Read More »

FDA Approves Tembexa (brincidofovir) for the Treatment of Smallpox

FDA Approves Tembexa (brincidofovir) for the Treatment of Smallpox DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) — Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Tembexa (brincidofovir) tablets and oral suspension approval… Read More »

FDA Approves Kimyrsa (oritavancin) for the Treatment of Adult Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

FDA Approves Kimyrsa (oritavancin) for the Treatment of Adult Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) MORRISTOWN, N.J., March 15, 2021 (GLOBE NEWSWIRE) — Melinta Therapeutics, LLC (Melinta), a commercial-stage company focused on the development and commercialization of novel antibiotics, today announced that the U.S. Food and Drug Administration (FDA) has approved… Read More »

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 »