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.
New Indication for Pradaxa
RIDGEFIELD, Conn., November 23, 2015 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Pradaxa® (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone hip replacement surgery.
FDA Approves Rx for Severe Aplastic Anemia
GlaxoSmithKline plc (GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the once-daily use of Promacta® (eltrombopag) in patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).
FDA Approves New Leukemia Treatment
The FDA has given some leukemia patients a new treatment option.
FDA Approves Pradaxa for Clotting Disorders
US regulators have approved a medication to treat and reduce two dangerous clotting disorders.
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.
FDA approves new indication for Promacta
GlaxoSmithKline announced today that the US Food and Drug Administration (FDA) has approved PROMACTA ® for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.
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.