FDA fast-tracks Shire treatment
Biopharmaceutical company Shire has received Fast Track designation from the US FDA for its enzyme replacement therapy velaglucerase alfa.
The therapy is being developed for the treatment of Type I Gaucher disease. Shire says it is working with the FDA to determine subsequent steps and timing for the filing of its new drug application.
The therapy is being developed for the treatment of Type I Gaucher disease. Shire says it is working with the FDA to determine subsequent steps and timing for the filing of its new drug application.
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