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Theravance’s Telavancin Data Integrity Issues Resolved; FDA Review Back On Track

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA will resume the review of Theravance’s antibiotic telavancin at a three-day advisory committee meeting in November after completing an audit of the company’s clinical trial data.

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Guidance on Anti-Infective Non-Inferiority Margins May Not Be Clear-Cut

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