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


GSK To Present Lotronex Risk Management “Progress Report” At May 5 Cmte.

This article was originally published in The Pink Sheet Daily

Executive Summary

The meeting comes nearly two years after FDA’s re-approval of the irritable bowel syndrome product. GSK’s risk management program is similar to Roche’s Accutane SMART program, which recently received a committee recommendation for an overhaul.

You may also be interested in...

Spectrum’s Iso-Vorin Could Clear FDA For Osteosarcoma By First Quarter

The Irvine, Calif., firm also plans sNDAs for a colorectal cancer claim and an oral formulation of the leucovorin relative.

Thelin's Third "Approvable" Letter Recommends Additional Clinical Trial

Encysive may be forced to make "significant reductions" to infrastructure and workforce, firm says June 15.

Sanofi Pentacel Revised Action Date Is Nov. 2

FDA extends the combination vaccine’s action date for the second time, this time requesting lab validation information relating to the pertussis component, but not directly related to Pentacel.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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