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Tysabri Accelerated Approval Based On Strength Of Effect, FDA Review Shows

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The degree of Tysabri's treatment effect in multiple sclerosis was integral to FDA's decision to grant the agent accelerated approval, review documents show

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Teva Jockeys For Advantage In Wake Of Tysabri Withdrawal, Avonex Warning

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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

September 2010 Approvals






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