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BioPharmaceutical

Bristol Sprycel Cardiovascular Issues Not Enough To Prevent Accelerated Approval

This article was originally published in Pharmaceutical Approvals Monthly

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  • Pharmaceutical Approvals Monthly

Executive Summary

QT prolongation appears to have been one of the primary safety considerations during FDA’s review of Bristol-Myers Squibb’s leukemia treatment Sprycel (dasatinib), review documents suggest.

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FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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