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J&J’s Sirturo Gets Panel Endorsement For Accelerated OK, Even As FDA Broaches Full Approval

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Anti-Infective Drugs Advisory Committee was fully satisfied with “sputum culture conversion” as a surrogate endpoint for accelerated approval, but turned back a last-minute question from FDA on traditional full approval for the tuberculosis drug bedaquiline.

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