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FDA News

Creator:   Editor
Created:   7/14/2014
Contains:  137 items
Actions, updates, and special reports from the U.S. Food and Drug Administration about oncology-related drugs.

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Priority Review to Keytruda for First-Line Treatment of Advanced Melanoma

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FDA Clearance for First Low-Dose CT Lung Cancer Screening System

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FDA Approves New Formulation of Onsolis for Breakthrough Pain

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FDA's Orphan Drug Status to Inecalcitol for AML

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FDA Approves Adcetris for Another HL Indication

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New Cancer-Related FDA Actions

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Orphan Drug Status to Melphalan for Cholangiocarcinoma

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Orphan Drug Designation to Anisina for Neuroblastoma

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FDA Approves Iressa for NSCLC, along with Companion Diagnostic

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Priority Review for MM-398 for Metastatic Pancreatic Cancer

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FDA Approves Promacta for Children with Chronic ITP

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FDA's Priority Review to Glioblastoma Therapy for Second Indication

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FDA's Breakthrough Designation to Venetoclax for CLL

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FDA Actions for Keytruda for NSCLC and GMI-1271 for AML

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FDA Approves Metastatic Colorectal Cancer KRAS Mutation Test

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FDA Gives Fast Track Designations to Drugs for AML, Pancreatic Cancer, NSCLC, and Prevention of Oral Mucositis

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Orphan Drug Designation to Cantrixil for Ovarian Cancer and Selumetinib for Uveal Melanoma

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Priority Review to Post-Transplant Consolidation Treatment for Hodgkin Lymphoma

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Xalkori Gets FDA Breakthrough Therapy Designation for NSCLC Indication

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Two FDA Advisory Committees Recommend Approval of Talimogene for Metastatic Melanoma

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