Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

You may also be interested in...



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 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

FDA granted a six-month priority review to Adeza’s NDA for the progesterone product under the 505(b)(2) pathway.

Topics

UsernamePublicRestriction

Register

PS143249

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel