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FDA panel backs Glaxo asthma drug for adults, not adolescents
Reuters The panel voted 16 to 4 that the product, Breo Ellipta, should be approved for once daily treatment of asthma in adults 18 years and older. It voted 19 to 1 that the data did not support approval for use in children aged 12 to 17. The FDA is not … Critical inspection of GlaxoSmithKline plc (ADR) (NYSE:GSK) by FDA … FDA panel backs Glaxo inhaler for adults, not adolescents GSK and Theravance Announce Outcome of US FDA Advisory Committee on … |
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