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November Gloom? US FDA’s Goal Dates Include Hard Calls On Ferring Rebyota, Y-mAbs’ Omblastys

Executive Summary

November should see FDA action on what could be the first standardized fecal microbiota transplant product, rare cancer therapies from Y-mAbs and Spectrum, uniQure/CSL’s hemophilia B gene therapy and Provention Bio’s biologic to delay type 1 diabetes.

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