Venclexta (Venetoclax) First BCL-2 Inhibitor Approved for High-Risk Relapsed Chronic Lymphocytic Leukemia
On September 23, 2016, the FDA approved adalimumab-atto (Amjevita; Amgen) as a biosimilar to adalimumab (Humira; AbbVie) for the treatment of several indications and inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis; moderate-to-severe Crohn’s disease; moderate-to-severe ulcerative colitis; and moderate-to-severe plaque psoriasis.
The FDA approved a first-of-its-kind device, Medtronic’s MiniMed 670G hybrid closed looped system, that will automatically monitor glucose and provide basal insulin doses in patients aged ≥14 years with type 1 diabetes. The MiniMed 670G hybrid closed looped system acts as an artificial pancreas, with little or no input needed from the user.
Tecentriq (Atezolizumab) First PD-L1 Inhibitor Approved for Patients with Advanced or Metastatic Urothelial Carcinoma
Urothelial carcinoma (also known as transitional-cell carcinoma) is the most common subtype of bladder cancer, accounting for more than 90% of bladder cancer diagnoses in the United States. In 2016, nearly 77,000 cases of bladder cancer are expected to be diagnosed in the United States, and more than 16,000 people will die from this disease. The incidence of bladder cancer increases with age, with a median age of 73 years at diagnosis.
Defitelio (Defibrotide Sodium): First Drug Approved for Patients with Hepatic Veno-Occlusive Disease
On March 30, 2016, the FDA approved defibrotide sodium (Defitelio; Jazz Pharmaceuticals) for hepatic veno-occlusive disease (VOD) with renal or pulmonary dysfunction after hematopoietic stem-cell transplant. This is the first drug approved for severe hepatic VOD. “The approval of Defitelio fills a significant need in the transplantation community to treat this rare but frequently fatal complication,” said Richard Pazdur, MD.
Cosentyx (Secukinumab): First IL-17A Antagonist Receives FDA Approval for Moderate-to-Severe Plaque Psoriasis
Keytruda (Pembrolizumab) First PD-1 Inhibitor Approved for the Treatment of Patients with Metastatic Non–Small-Cell Lung Cancer Expressing PD-L1
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Results 1 - 10 of 11
Results 1 - 10 of 11