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FDA News

Creator:   Editor
Created:   7/14/2014
Contains:  86 items
Actions, updates, and special reports from the U.S. Food and Drug Administration about oncology-related drugs.

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FDA's Orphan Drug Designation for AML Drug

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FDA Grants Breakthrough Therapy Status to Ixazomib for AL Amyloidosis and JCAR015 for Relapsed/Refractory ALL

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FDA Approval for Jakafi for Chronic bone marrow Disease

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FDA's ‘QIDP’ Designation to H. Pylori Eradication Drug

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FDA Approves Avastin Plus Chemotherapy for Ovarian Cancer

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FDA Approves Cyramza-Paclitaxel Combo for Advanced Gastric Cancer

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TAS-102 Gets Fast Track Status for Refractory Metastatic Colorectal Cancer

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FDA's Breakthrough Designation to Keytruda for NSCLC

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Lymphoseek Now FDA-Approved for All Solid Tumors

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FDA Actions for Lung Cancer and Glioma Drugs

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Priority Review to Blinatumomab for Acute Lymphoblastic Leukemia

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Priority Review to Lenvatinib for Thyroid Cancer Indication

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FDA Approves Another Indication for Velcade for Mantle Cell Lymphoma

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FDA Approves Akynzeo for Chemo-Induced Nausea and Vomiting

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Orphan Drug Designation to Aldoxorubicin for Glioblastoma, Small Cell Lung Cancer, & Ovarian Cancer

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Orphan Drug Status Given to Lymphoseek for New Indication for Head and Neck Cancers, and RX-3117 for Pancreatic Cancer

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FDA Grants Priority Review to Somatuline for GEP-NETs

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New FDA Indication for Xtandi for Prostate Cancer

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Keytruda Approved by FDA for Advanced Melanoma, Called ‘Game Changer’

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Support & Concerns about FDA's Recent Actions on Diagnostics

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