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

Horizon Teprotumumab's US Advisory Cmte. Likely To Focus On Labeling, Not Approval, Questions

Executive Summary

FDA seems poised to approve the drug for the orphan eye disease called TED, but remains concerned about labeling for some adverse events.

You may also be interested in...



Postmarketing Trial For Horizon Thyroid Eye Drug Tepezza To Be Larger Than Expected

Horizon CEO says safety trial will be conducted in a larger patient population following discussions during the US FDA advisory committee meeting.

Horizon's Teprotumumab Breezes Through US FDA Adcom, But Safety Questions Remain

Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS141348

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