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Review Pathway Drug Approval Standards Approvals

Biogen Spinraza Approval: The Perfect Antidote To Sarepta Headlines?

  • Opinion

Executive Summary

Approval of Biogen/Ionis’ Spinraza gives the drug development community a successful, collaborative model for a rapid pathway to full approval for a rare disease therapy; it also provides a timely, compelling rebuttal to claims that US FDA’s drug review operations are in dire need of reform.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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