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BRIEF-Glaxosmithkline says submission of supplemental biologics license application to US FDA
2017年11月7日 / 下午3点09分 / 11 天内

BRIEF-Glaxosmithkline says submission of supplemental biologics license application to US FDA

Nov 7 (Reuters) - GLAXOSMITHKLINE PLC:

* ‍US REGULATORY APPLICATION FOR MEPOLIZUMAB IN COPD​

* ‍ANNOUNCED SUBMISSION OF A SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION (SBLA) TO UNITED STATES FOOD AND DRUG ADMINISTRATIO​

* ‍SUBMISSION INCLUDES PHASE III DATA FROM PREVIOUSLY REPORTED 1,2 METREX AND METREO STUDIES.​

* ‍SEEKING APPROVAL OF MEPOLIZUMAB, AN INTERLEUKIN-5 (IL-5) ANTAGONIST

* ‍REGULATORY FILINGS IN OTHER COUNTRIES ARE PLANNED DURING COURSE OF 2017 AND 2018.​ Source text for Eikon: Further company coverage: (Bangalore.newsroom@thomsonreuters.com)

我们的标准:汤森路透“信任原则”
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