Shire/TKT I2S Hunter Syndrome BLA, MAA Slated For Fourth Quarter
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Transkaryotic Therapies is planning a fourth-quarter BLA submission for its Hunter syndrome enzyme replacement therapy I2S, the firm said June 20
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Shire Submits Elaprase BLA For Hunter Syndrome
Shire's Elaprase (idursulfase) could be approved as early as May 2006 for Hunter syndrome if FDA grants the company's request for priority review of the BLA submission, announced Nov. 24
Approvals In Brief
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