Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Preterm Birth Patients Sought By US FDA As Meeting On Treatment Development Looms

Executive Summary

With the only FDA-approved treatment off the market, the FDA is looking for ideas for development of new preterm birth treatments.

You may also be interested in...



Opportunities In Fertility: Recognizing Gaps In The Market

Ferring Pharmaceuticals’ US CSO Elizabeth Garner talks to In Vivo about the future of fertility and where investment should be heading to make a dent in this multi-million-dollar market.

Organon Widens Business Development Lens To Maintain Women’s Health Focus

Organon has not strayed from its women’s health path, but is entering into earlier deals and considering technologies beyond therapeutics, while advocating increased investment in the field.

Makena Vs. Avastin: No Contest When It Came To Withdrawal Process Duration

Approximately 41 months passed from the initial advisory committee meeting in October 2019 on Makena’s potential withdrawal to the 5 April 2023 final decision by FDA's commissioner and chief scientist - more than double the length of the same interval in the accelerated approval withdrawal proceeding involving the breast cancer claim for Genentech's Avastin.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS149445

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