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GSK’s Breo Ellipta: FDA Panel To Weigh Large Safety Study For Asthma Claim

This article was originally published in The Pink Sheet Daily

Executive Summary

LABA safety issues may come to haunt GlaxoSmithKline as FDA’s Pulmonary-Allergy Drugs and Drug Safety and Risk Management advisory committees will focus on the combination’s product’s safety database and whether an outcomes study is needed for approval in asthma.

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