FDA Agrees To Accelerated Approval For Myozyme Scale-Up, Genzyme Says
The 2,000L version of Myozyme on track for approval with a post-market confirmatory trial in February; user fee date extended while FDA reviews REMS submission.
The 2,000L version of Myozyme on track for approval with a post-market confirmatory trial in February; user fee date extended while FDA reviews REMS submission.