FDA Alerts
FDA Approves New Rx, Xofigo
The US Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs.
FDA Approves Companion Diagnostic to Detect Gene Mutation
The US Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib).
FDA Issues Proposal to Increase Consumer Awareness of Tanning Bed Risks
Today, the US Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.
FDA Approves Lymphoseek to Help Locate Lymph Nodes
The US Food and Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.
FDA Approves Stivarga for Advanced Gastrointestinal Stromal Tumors
The US Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease.
FDA Approves New Treatment for Late-Stage Breast Cancer
The US Food and Drug Administration today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.
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 Approval of Generic Doxil is Expected to Help Resolve Shortage
The U.S. Food and Drug Administration today approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection).
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.