FDA Approvals, News & Updates

FDA Update

August 2014, Vol 4, No 5 - FDA Approvals, News & Updates

Ofatumumab Approved for Chronic Lymphocytic Leukemia The US Food and Drug Administration approved ofatumumab (Arzerra Injection, GlaxoSmithKline) in combination with chlor­ambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia, for whom fludarabine-based therapy is considered inappropriate. The [ Read More ]

FDA Update

May 2014, Vol 4, No 3 - FDA Approvals, News & Updates

Zykadia Approved for Metastatic, ALK-Positive Lung Cancer On April 29, 2014, the US Food and Drug Administration (FDA) approved ceritinib (Zykadia; Novartis) for the treatment of patients with metastatic, anaplastic lymphoma kinase (ALK)-positive non–small-cell lung cancer (NSCLC). Ceritinib is an [ Read More ]

FDA Update

March 2014, Vol 4, No 2 - FDA Approvals, News & Updates

First Drug Combination Approved for Unresectable or Metastatic Melanoma The US Food and Drug Admin­istration (FDA) approved the use of dabrafenib (Tafinlar; GlaxoSmith­Kline) plus trametinib (Mekinist; GlaxoSmithKline) as a new combination therapy for the treatment of patients with advanced melanoma [ Read More ]