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FDA News

Creator:   Editor
Created:   7/14/2014
Contains:  65 items
Actions, updates, and special reports from the U.S. Food and Drug Administration about oncology-related drugs.

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FDA Orphan Drug Designation to Drugs for Glioblastoma & DBCL

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FDA Fast-Tracks AG-221 for AML with IDH2 Mutation

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New FDA Actions Designed to Ensure Reliability of Diagnostics

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FDA Approves Velcade Retreatment for Multiple Myeloma

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FDA Approves Indications for Idelalisib for Three Blood Cancers—CLL, FL, and SLL

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FDA Approves First Non-Invasive Colorectal Cancer Screening Test

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FDA Grants Priority Review to Avastin for Two Indications

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Breakthrough Status to Pancreatic Cancer Immunotherapy

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FDA Expands Approved Use of Ibrutinib for CLL

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FDA's Breakthrough Designation to Blinatumomab and CTL019 for ALL

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FDA Approves Lymphoseek to Help Determine Extent of Head and Neck Cancer

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ODAC Votes No on Accelerated Approval of Olaparib for Ovarian Cancer Maintenance Therapy

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FDA Approves Drug to Prevent Chemotherapy-Induced Nausea and Vomiting in Children as Young as One Month

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FDA Approves MRI Contrast Agent for Improved Evaluation of Breast Cancer

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FDA Grants Breakthrough Therapy Status to MPDL3280A for Bladder Cancer

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FDA Grants Orphan Drug Status to ADXS-cHER2 for Osteosarcoma

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FDA Approval for Vectibix & Companion Diagnostic; Breakthrough Status for Elotuzumab & CO-1686

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Orphan Drug Status to Selinexor for DLBCL

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FDA's Breakthrough Therapy Designation: Update from Janet Woodcock

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Pancreatic Cancer Drug Demcizumab Receives Orphan Drug Designation

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