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BioBS2012

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BioBS2012

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Wednesday, 09/02/2015 9:24:56 AM

Wednesday, September 02, 2015 9:24:56 AM

Post# of 345784
While we await the first rays from SUNRISE.....


U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo (nivolumab) in Previously Treated Non-Squamous Non-Small Cell Lung Cancer Patients

Submission based on positive results of the landmark, global Phase 3 study, CheckMate -057 evaluating overall survival versus standard of care in non-squamous non-small cell lung cancer patients

U.S. FDA grants application priority review, and Opdivo Breakthrough Therapy Designation for this indication; marks third indication for Opdivo to receive this designation

Wednesday, September 2, 2015 8:00 am EDT


http://news.bms.com/press-release/us-food-and-drug-administration-accepts-supplemental-biologics-license-application-o-0?linkId=16739957
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