Tag Archives: Approves

FDA Approves Rylaze for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

FDA Approves Rylaze 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 the treatment of acute… Read More »

U.S. FDA Approves ALK’s Ragwitek (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Children and Adolescents With Short Ragweed Pollen-Induced Allergic Rhinitis With or Without Conjunctivitis

ROUND ROCK, Texas, April 19, 2021 /PRNewswire/ — ALK (ALKB: DC / OMX: ALK B / AKABY / AKBLF), a global, research-driven pharmaceutical company that focuses on the diagnosis and treatment of allergies, announced that the U.S. Food and Drug Administration (FDA) approved Ragwitek (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use for the… 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 Cosela (trilaciclib) to Decrease the Incidence of Chemotherapy-Induced Myelosuppression

FDA Approves Cosela (trilaciclib) to Decrease the Incidence of Chemotherapy-Induced Myelosuppression RESEARCH TRIANGLE PARK, N.C., Feb. 12, 2021 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Cosela (trilaciclib) for injection to decrease the incidence of chemotherapy-induced myelosuppression in adult… Read More »

FDA Approves Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets for Colonoscopy Preparation

FDA Approves Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets for Colonoscopy Preparation BRAINTREE, Mass., Nov. 10, 2020 /PRNewswire/ — Sebela Pharmaceuticals® today announces that the U.S. Food and Drug Administration (FDA) approved Sutab® (sodium sulfate, magnesium sulfate, and potassium chloride) tablets. Sutab, a sulfate-based tablet preparation for colonoscopy, was developed and will be… 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 »