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

UsernamePublicRestriction
UsernamePublicRestriction

Shire’s Mesavance User Fee Date Extended To Jan. 21

This article was originally published in The Pink Sheet Daily

Executive Summary

Delay allows FDA to review supplemental Phase I dose absorption study for ulcerative colitis treatment.

You may also be interested in...



Shire's Lialda Launch For Ulcerative Colitis Will Focus On Dosing Convenience

Shire is planning an sNDA for a remission maintenance claim within two years, the firm tells "The Pink Sheet" DAILY.

Shire's Lialda Launch For Ulcerative Colitis Will Focus On Dosing Convenience

Shire is planning an sNDA for a remission maintenance claim within two years, the firm tells "The Pink Sheet" DAILY.

Salix Gets FDA Approval For Colazal in Pediatric UC Patients

Colazal becomes first 5-ASA approved for pediatric ulcerative colitis, firm says.

Topics

UsernamePublicRestriction

Register

PS064987

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