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FDA News

Creator:   Editor
Created:   7/14/2014
Contains:  115 items
Actions, updates, and special reports from the U.S. Food and Drug Administration about oncology-related drugs.

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Orphan Drug Status Given to IMO-8400 for Diffuse Large B-Cell Lymphoma

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FDA Approval for Label Update for Zytiga; Orphan Drug Status for Reolysin and CRS-07

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FDA Approves New Oral Formulation of Deferasirox (Jadenu) for Chronic Iron Overload

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FDA Grants Priority Review to Kyprolis for Multiple Myeloma

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FDA's Fast Track Status to Nonmuscle-invasive Bladder Cancer Drug

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Glioblastoma Drug Gets FDA Breakthrough Therapy Designation

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FDA Approval for Unituxin for Pediatric High-risk Neuroblastoma

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FDA Expands Approved Use of Opdivo (Nivolumab) for Lung Cancer

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FDA Approves First Biosimilar for United States: Zarxio (Filgrastim-sndz)

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Orphan Drug Designation to LEP-ETU for Ovarian Cancer

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FDA Actions for Drugs for EBV Lymphoproliferative Disease and Fallopian Tube Cancer

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FDA Expands Revlimid Indication for All Patients with Multiple Myeloma

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FDA Approves Farydak (Panobinostat) for Multiple Myeloma

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Approval for Palbociclib for Metastatic Breast Cancer

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FDA Priority Review to Soft Tissue Sarcoma Drug

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FDA Approval for Lenvatinib for Thyroid Cancer Indication

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FDA's Breakthrough Designation to Anti-PDL1 Immunotherapy for NSCLC

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Recent FDA Actions for Oncology Products

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FDA's Fast Track Designation to Drug for Metastatic Triple-Negative Breast Cancer

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FDA Approves Gazyva Combo Treatment for CLL

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