Tag Archives: Approves

FDA Approves Spravato (esketamine) Nasal Spray for Treatment-Resistant Depression

Print this page March 5, 2019 — The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Because of the risk of serious adverse outcomes resulting… Read More »

FDA Approves Imbruvica (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia

Print this page HORSHAM, Pa., Jan. 28, 2019 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of Imbruvica (ibrutinib) in combination with obinutuzumab in treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), the most common form of leukemia in adults.1 This is… Read More »

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

Home News New Drugs FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin Print this page January 18, 2019 — FDA today approved Ontruzant (trastuzumab-dttb), a biosimilar to U.S.-licensed Herceptin (trastuzumab). A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA approved biological product,… Read More »