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

Tasigna Approval May Be Again Delayed To Allow FDA Advisory Cmte. Review – Novartis

This article was originally published in The Pink Sheet Daily

Executive Summary

NDA for next-generation chronic myeloid leukemia therapy currently has late October action date, but FDA may convene ODAC to review Tasigna in December.

You may also be interested in...



Novartis’ Tasigna Approved By FDA For CML Patients Resistant to Gleevec

The Bcr-Ab1 inhibitor will be available in the U.S. “within days,” the company says.

Novartis’ Tasigna Approved By FDA For CML Patients Resistant to Gleevec

The Bcr-Ab1 inhibitor will be available in the U.S. “within days,” the company says.

No Big Surprise For Novartis: Prexige Is “Not Approvable” At FDA

Firm now plans to discuss path forward, which may include additional trials of the COX-2 inhibitor, with FDA, Novartis tells "The Pink Sheet" DAILY.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS066595

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