5. FDA OKs Relaunch of Novel Intravenous Immune Globulin Product
The FDA approved a Prior Approval Supplement for immune globulin intravenous (human), 10% liquid (Bivigam, ADMA Biologics) for patients with primary humoral immunodeficiency disease. Read more.
4. FDA Grants Breakthrough Designation to Treatment for Kaposi Sarcoma
Pomalidomide (Pomalyst, Celgene) showed clinical benefit in patients with Kaposi sarcoma, regardless of HIV status. Read more.
3. FDA OKs First Anti-PD-L1 Therapy in Combo Regimen for Advanced Kidney Cancer
Avelumab (Bavencio) plus axitinib (Inlyta) is indicated for the first-line treatment of patients with advanced renal cell carcinoma. Read more.
2. FDA Committee Votes Against Quizartinib Approval for Acute Myeloid Leukemia
The FDA’s Oncology Drugs Advisory Committee challenged the results of the phase 3 QuANTUM-R study. Read more.
1. FDA Approves Combo Therapy for Untreated Chronic Lymphocytic Leukemia
The approval of venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) offers an additional option for adults with previously-untreated chronic lymphocytic leukemia. Read more.