Tag Archives: approves

FDA approves ketamine-like nasal spray for depression

It will be sold as Spravato. More specifically, it’s for patients who have tried at least two other medications without success, and it should be taken with an oral antidepressant. “There has been a longstanding need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” Dr. Tiffany Farchione, acting director of the… Read More »

FDA Approves Darzalex (daratumumab) Split-Dosing Regimen

Print this page Horsham, PA, February 12, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a split-dosing regimen for Darzalex® (daratumumab), providing healthcare professionals and patients with multiple myeloma an option to split the first infusion over two consecutive days.[1] The… Read More »

FDA Approves Egaten (triclabendazole) for the Treatment of Fascioliasis, a Neglected Tropical Disease

Print this page Basel, Switzerland, February 13, 2019 – Novartis announced today that the US Food and Drug Administration (FDA) has approved Egaten (triclabendazole) for the treatment of fascioliasis in patients six years of age and older. This makes Egaten the only FDA-approved drug for people with this disease and is expected to facilitate broader… Read More »

FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin

Print this page INCHEON, KOREA – January 21, 2019 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceptin®i (trastuzumab), across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma… Read More »