GSK, Theravance’s Breo Faces Scrutiny Over Safety for Asthma – Bloomberg


Reuters

GSK, Theravance's Breo Faces Scrutiny Over Safety for Asthma
Bloomberg
(Bloomberg) — GlaxoSmithKline Plc and Theravance Inc.'s respiratory drug Breo Ellipta will face questions from a regulatory panel over the safety of expanding its use to treat asthma patients and whether it's suitable for children. Advisers to the U.S
FDA staff finds no new safety problems with Glaxo's asthma drugReuters
GSK Studies Found No Asthma Deaths For COPD Drug, FDA SaysLaw360 (subscription)
New Glaxo asthma treatment reviewed by FDANational Monitor

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GSK and Theravance submit US sNDA for Breo Ellipta in asthma – The Pharma Letter


The Pharma Letter

GSK and Theravance submit US sNDA for Breo Ellipta in asthma
The Pharma Letter
Today's filing is based on data generated from the comprehensive clinical development program for FF/VI in asthma. The clinical development program comprised 48 clinical pharmacology studies in 1,328 subjects and 23 clinical studies in 12,051 patients …
Glaxo, Theravance File Asthma Drug Application with FDANASDAQ
Glaxo submits new drug application for asthma treatmentIFA Magazine
GSK and Theravance Announce Submission to US Regulatory Authorities for MarketWatch
RTT News
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