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


Bristol Sprycel Cardiovascular Issues Not Enough To Prevent Accelerated Approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

QT prolongation appears to have been one of the primary safety considerations during FDA’s review of Bristol-Myers Squibb’s leukemia treatment Sprycel (dasatinib), review documents suggest.

You may also be interested in...

Pfizer Sutent Review: Partial Response Could Mean Clinical Benefit In RCC Setting

FDA’s decision to grant Pfizer’s Sutent a broad renal cell carcinoma claim suggests a consensus among reviewers that partial responses may be predictive of clinical benefit in RCC.

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

September 2010 Approvals






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