12:00 AM
Mar 19, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Replagal agalsidase alfa regulatory update

Shire withdrew a BLA for Replagal agalsidase alfa to treat Fabry's disease and said it does not intend to resubmit the application. Shire said that based on recent interactions with FDA, it believes the agency will require additional controlled studies before approving the drug. The application was under Priority Review with a May 17 PDUFA date. As...

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