News Releases

Bendeka Gets the Green Light
JERUSALEM & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) today announce that the U.S. Food and Drug Administration (FDA) has approved BENDEKA™, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine.
FDA Approves New Leukemia Treatment
The FDA has given some leukemia patients a new treatment option.
FDA Approves Gazyva for Chronic Lymphocytic Leukemia
The US Food and Drug Administration today approved Gazyva ( obinutuzumab ) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).
FDA Grants Janssen Research & Development Breakthrough Therapy Designation for Daratumumab
Janssen Research & Development, LLC (Janssen) announced the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and IMiD.
Pfizer’s BOSULIF Receives Conditional Marketing Authorization From The European Commission
Pfizer Inc. announced today that the European Commission (EC) has granted conditional marketing authorization for BOSULIF ® (bosutinib) in the European Union (EU) for the treatment of adult patients with chronic phase (CP), accelerated phase (AP) and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Chronic Myelogenous Leukemia Drug Approved
Pfizer Inc. announced the US Food and Drug Administration (FDA) has approved BOSULIF (bosutinib), an Abl and Src kinase inhibitor, for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance, or intolerance to prior therapy.
FDA Approves Subcutaneous Administration of Takeda Drug Velcade
The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application ( sNDA ) for Velcade ( bortezomib ).
Merck Announces Multiple Myeloma Drug Trial Results
Merck  announced today that a Phase III study of Zolinza ( vorinostat ), for investigational use in combination with bortezomib in patients with progressive multiple myeloma , met its primary endpoint, demonstrating a 23 percent reduction in the risk of progression compared to the standard therapy of bortezomib (p=0.01).
Erwinaze Approved to Treat Leukemia
The U.S. Food and Drug Administration has approved Erwinaze ( asparaginase Erwinia chrysanthemi ) to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs used to treat ALL.
FDA Approves Drug to Treat Two Lymphomas
The U.S. Food and Drug Administration has approved Adcetris (brentuximab vedotin) to treat Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL).