FDA Alerts
FDA Approves New Leukemia Rx
On January 19, 2016, the U.S. Food and Drug Administration approved ofatumumab (Arzerra Injection, Novartis Pharmaceuticals Corporation) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL).
FDA Approves First Test for Group of Human Retroviruses
The U.S. Food and Drug Administration today approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II).
FDA Approves Blincyto to Treat Rare Form of Leukemia
The U.S. Food and Drug Administration today approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.
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 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.
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.