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See Latest ArticlesShire Targets Fourth Quarter Filing of BLA for REPLAGAL? for Fabry Disease with U.S. FDA
Shire, 10/22/09
Shire plc, the global specialty biopharmaceutical company, announces plans to file a Biologics License Application with the U.S. Food and Drug Administration for REPLAGAL, its enzyme replacement therapy for Fabry disease, by the end of the year. The Company also announces that a treatment protocol for REPLAGAL, filed at the request of FDA, has been approved, and that it will support emergency IND requests.
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Novartis, 09/18/09
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