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FDA News

Creator:   Editor
Created:   7/14/2014
Contains:  102 items
Actions, updates, and special reports from the U.S. Food and Drug Administration about oncology-related drugs.

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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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ODAC Casts Historic Vote Advising Approval of Investigational Filgrastim Biosimilar Drug

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Nivolumab Gets Accelerated Approval for Metastatic Melanoma

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Accelerated Approval for Olaparib for Advanced Ovarian Cancer, along with Companion Diagnostic Test

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FDA's Fast-Track Designation to DPX-Survivac for Ovarian Cancer

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FDA's Fast Track Designation to Necuparanib for Metastatic Pancreatic Cancer

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FDA Approval for Somatuline Depot (Lanreotide) Injection for GEP-NETs

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FDA Approves Blincyto for ALL Indication

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New Gardasil Vaccine Approved to Prevent Cancers Caused by 5 Additional HPV Types

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FDA Approves Cyramza for Aggressive NSCLC

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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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