FDA Alerts
FDA Approves Pomalyst for Advanced Multiple Myeloma
The US Food and Drug Administration today approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.
FDA Approves Gleevec for Children With Acute Lymphoblastic Leukemia
The US Food and Drug Administration today approved a new use of Gleevec ( imatinib ) to treat children newly diagnosed with Philadelphia chromosome positive ( Ph +) acute lymphoblastic leukemia (ALL).
FDA Approves Exjade for Genetic Blood Disorder
The US Food and Drug Administration today expanded the approved use of Exjade (deferasirox) to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT).
FDA Approves Eliquis for Atrial Fibrillation Patients
The US Food and Drug Administration today approved the anti-clotting drug Eliquis ( apixaban ), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
FDA approves Iclusig to treat two rare types of leukemia
The US Food and Drug Administration today approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases.
FDA Drug Safety Communication: Important Change to Heparin Container Labels
The US Food and Drug Administration (FDA) is notifying healthcare professionals, caregivers, and patients about a change to the container and carton labels for heparin products, which are blood-thinning agents that prevent the formation of blood clots.
FDA expands use of Xarelto to treat, reduce recurrence of blood clots
The US Food and Drug Administration today expanded the approved use of Xarelto (rivaroxaban) to include treating deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment.
Synribo for Chronic Myelogenous Leukemia Approved by FDA
The US Food and Drug Administration today approved Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease.
Revlimid and Risk of New Cancers
The U.S. Food and Drug Administration (FDA) is informing the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid ( lenalidomide ).
Cephalon, Inc. Issues Voluntary Nationwide Recall of Treanda
Cephalon , Inc. is voluntarily recalling Treanda ® ( bendamustine HCL ) for Injection 25mg / 8mL ; lot TB30111 , expiration date 12/2012. This product lot is being recalled due to the presence of particulate matter found in a single vial, which has been identified as glass fragments.