Adeza’s Gestiva Review To Consider The Validity Of Pivotal Trial’s Primary Endpoint
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s Reproductive Health Drugs Advisory Committee will discuss the preterm birth agent during an Aug. 29 meeting.
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FDA’s Reproductive Health Advisory Committee votes that safety and efficacy of Adeza’s preterm birth agent Gestiva have been demonstrated.
Gestiva Passes Cmte. Review, But Further Study Of Miscarriage Risk Requested
FDA’s Reproductive Health Advisory Committee votes that safety and efficacy of Adeza’s preterm birth agent Gestiva have been demonstrated.
Gestiva Preterm Birth Drug Could Be Approved In October
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