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

FDA Accentuates Venclexta Superiority To Imbruvica

Executive Summary

FDA denied breakthrough therapy request until AbbVie and Roche demonstrated substantial improvement over available treatment in 17p deletion chronic lymphocytic leukemia, review documents show.

You may also be interested in...



US FDA May Reconsider RMAT Requests If Resubmitted With Sufficient Clinical Data

Rejection of an RMAT request does not mean necessarily mean the FDA won't grant one. The agency will accept new clinical data to support the application through a “reconsideration” process, industry official says.

Drug Review Profiles: Behind The Scenes At US FDA

A year in our long-running series of deep dives into FDA review documents.

US FDA's Search For Meaning: Interpretation Of Regulatory Language Can Inspire Conflict In Drug Reviews

The Pink Sheet's Drug Review Profile series illustrates the challenge of reconciling review realities and broad statutory directives.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS057714

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