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End Of An Accelerated Approval Odyssey: Covis Agrees To Withdraw Makena But Seeks 21-Week ‘Wind-Down’

Executive Summary

Covis says it respects advisory committee vote at October public hearing favoring withdrawal; proposal comes four years after failure of the PROLONG confirmatory trial to confirm clinical benefit in preventing preterm birth.

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Accelerated Approval: US FDA, Covis Navigate Novel Issues With Makena’s Withdrawal

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