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 Vaxelis Pediatric Hexavalent Combination Vaccine

FDA Approves Vaxelis Pediatric Hexavalent Combination Vaccine Print this page BRIDGEWATER, N.J. and KENILWORTH, N.J. – December 26, 2018 –The U.S. Food and Drug Administration has approved Vaxelis™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) for use in children from 6… Read More »