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Glaxo, Theravance File Asthma Drug Application with FDA
NASDAQ LONDON–GlaxoSmithKline PLC (GSK.LN) and Theravance Inc. ( THRX ) have submitted a supplemental new drug application to the U.S. Food and Drug Administration for a drug used for treatment of asthma in patients aged 12 years and older. The British … GSK and Theravance Announce Submission to US Regulatory Authorities for … Glaxo And Theravance Submits Supplemental NDA For Breo Ellipta |
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GSK and Theravance file for FF/VI approval in the USA and Europe; Talks with …
The Pharma Letter Asthma (100/25mcg and 200/25mcg): The regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate. • COPD (100/25mcg): The … GSK, Theravance seek approvals for FF/VI in US, Europe GSK and Theravance file next-generation Advair in USA, EU |
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 Telegraph.co.uk |
GSK and Theravance to file COPD/asthma drug
The Pharma Letter For asthma, GSK plans to submit an application in Europe in mid-2012 and will continue discussions with the Food and Drug Administration on the regulatory requirements for a US asthma indication. Despite some mixed clinical trial results with Relovair … GSK, Theravance report completion of Relovair studies in COPD and asthma GSK and Theravance Announce Initial Outcomes From Pivotal Phase III Studies … Theravance Falls Most in 3 Years After Glaxo Drug Fails |
View full post on asthma – Google News