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

Increased Cancer Risk & Effectiveness Concerns Prompt EU-Wide Review Of Preterm Birth Medicine

Executive Summary

The European Medicines Agency is re-examining the benefits and risks of hydroxyprogesterone medicines for gynecologic and obstetrical conditions at the request of the French regulator ANSM.

You may also be interested in...



Supplemental Filings: Back To US FDA’s Conference Center, What Marks Wants In A Gene Therapy Director, And More

Short stories about how US FDA’s conference center changed since COVID-19 forced the end of in-person public events, what the agency did to officially close the books on Makena, and more.

Makena: Professional Societies Finally See Eye To Eye With US FDA’s Drugs Center

After two decades of recommending use of intramuscular 17-OHPC to prevent preterm birth, the American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine revised their clinical guidelines in the wake of the FDA’s order withdrawing Covis’ Makena and its generics.

EMA To Explain How Trial Transparency & Data Redaction Can Live Together

The European Medicines Agency is working to align the redaction and data anonymization principles underpinning two EU clinical trial transparency initiatives to ensure consistency in disclosure requirements.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS148209

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