Genzyme, a company producing therapies for rare diseases, received FDA clearance for its manufacturing plant in Framingham, Mass., for the production of Fabrazyme, an enxyme replacement therapy for Fabry disease, according to a news release.
The approval allows Genzyme to begin returning patients to full doses of Fabrazyme. By March, patients in the U.S. will be returned to full dosing. Normal supply levels are expected by the second quarter.
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The approval allows Genzyme to begin returning patients to full doses of Fabrazyme. By March, patients in the U.S. will be returned to full dosing. Normal supply levels are expected by the second quarter.
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FDA, Life Sciences Trade Group Partner to Improve Medical Device Review