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In collaboration with the Food and Drug Administration (FDA), and as a service to our members, ASH provides information about newly approved therapies for patients. This will allow the agency to inform hematologists and professionals in hematology-related fields of recent approvals in a timely manner. Included in the announcement from the FDA is a link to the product label, which will provide the relevant clinical information on the indication, contraindications, dosing, and safety. In sending this information, ASH does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described. The following are recent announcements from the FDA's Office of Oncology Drug Products Director, Dr. Richard Pazdur:
FDA Approves Treanda for Patients With CLL (March 20, 2008)
FDA Approves Sprycel for Certain Adults With Chronic Phase CML (November 8, 2007)
FDA Approves New Boxed Warnings and Other Safety-Related Product Labeling Changes for ESAs (November 8, 2007)
FDA Approves Nilotinib for Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (October 29, 2007)
FDA Approves Alemtuzumab for the Treatment of B-CLL (September 20, 2007)
FDA Approves Dexrazoxane Hydrochloride for Injection (September 7, 2007)
FDA Approves Temsirolimus for Treatment of Advanced RCC (May 31, 2007)
FDA Approves Doxorubicin HCl Liposome Injection (DOXILR) in Combination With Bortezomib in Patients With Multiple Myeoma (May 18, 2007)
FDA Approves Fragmin to Reduce Recurrence of Symptomatic VTE in Patients With Cancer (May 2, 2007)
FDA Approves Soliris for Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) to Reduce Hemolysis
(March 16, 2007)
FDA Safety Update on Erythropoietin-Stimulating Agents (ESAs) - Aranesp, Epogen, Procrit (March 09, 2007)
FDA Announcement Regarding Aranesp® Evolving Safety Information (February 23, 2007)
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