FDA News

Recent Drug Approvals

February 2015, Vol 5, No 1 - FDA News

Jakafi Gets New Indication for Use in Patients with Polycythemia Vera The FDA approved ruxolitinib (Jakafi; Incyte Corporation) for the treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. The [ Read More ]

Recent Drug Approvals

November 2014, Vol 4, No 7 - FDA News

FDA Approves First Anti–PD-1: Pembrolizumab Indicated for Advanced Melanoma The FDA approved the first ­­anti–programmed death receptor-1 (PD-1) therapy, pembrolizumab (Keytruda; Merck), for patients with unresectable or metastatic melanoma and disease progression after treatment with other melanoma therapy, such as [ Read More ]

FDA Update

August 2014, Vol 4, No 5 - FDA News

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 News

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 News

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 ]