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You are here: Industry Insights > Breakthrough Therapy Designation

News List

WuXi Biologics Congratulates Amicus on Receiving FDA Breakthrough Therapy Designation for AT-GAA en-cphi.cn
March 01, 2019
The second product successfully receiving Breakthrough Therapy Designation that WuXi Biologics has enabled its partner to develop
Pfizer receives Breakthrough Therapy designation for inhibitor drug biospectrumasia
September 07, 2018
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

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