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FDA Accepts Onyx’s Carfilzomib Application But Denies Priority Review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

“Our plan is to continue our dialogue with the FDA and see if we can address their concerns and get the accelerated approval done,” Onyx R&D chief Love told analysts. The company completed its application to treat patients with refractory and relapsed multiple myeloma in September based on results of a single-arm study, a design the agency may not be inclined to accept.

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