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FDA Panel Breathes New Life Into Telavancin For Nosocomial Pneumonia

This article was originally published in The Pink Sheet Daily

Executive Summary

The Anti-Infective Drugs Advisory Committee votes 13-2 in favor of a limited indication for Theravance’s antibiotic, particularly for use in treating methicillin-resistant infections. The endorsement comes after a nearly four-year regulatory battle over the NDA.


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Mortality Vs. Clinical Cure: Telavancin Review Expected To Renew Debate On Nosocomial Pneumonia Endpoints
Theravance’s Vibativ To Get FDA Panel Review For Hospital-Acquired Pneumonia


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