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


Rare Lymphoma Risk Haunts Remicade Expansion To Pediatric Ulcerative Colitis

Executive Summary

Determining how to handle the risk of rare, but deadly, hepatosplenic T-cell lymphoma with Centocor’s Remicade (infliximab) will be one of the tasks FDA faces as it decides whether to expand the biologics’ indication for ulcerative colitis to pediatric patients.

You may also be interested in...

Humira Will Get Advisory Committee Review For Ulcerative Colitis

FDA’s Gastrointestinal Drugs Advisory Committee is scheduled to review Abbott’s sNDA for the TNF blocker Humira Aug. 28.

FDA Boosts Surveillance Requirements For TNF Blockers In Effort To Track Lymphoma

Manufacturers must conduct in-depth follow-up of reported malignancies in children and young adult patients and submit them to FDA within 15 days of learning about the cases.

FDA Advisory Committee Waivers Reflect Recruitment Challenges

Recent waivers allowing the participation of outside experts at drug-related advisory committee meetings reflect FDA's difficulties in finding qualified individuals to provide advice on specialized topics.

Related Content


Latest Headlines
See All



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