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

Luveniq Advisory Committee: Renal Side Effects May Be Key Issue With Immunosuppressant

This article was originally published in The Pink Sheet Daily

Executive Summary

Lux Biosciences' Luveniq (voclosporin) for uveitis will undergo review by FDA's Dermatologic and Ophthalmic Drugs Advisory Committee on June 28.

You may also be interested in...



FDA Says Lux's Uveitis Treatment Luveniq Needs Another Clinical Trial

Lux Biosciences will have to do another clinical trial - on top of three already completed Phase III studies - for FDA to consider approving its uveitis treatment Luveniq (voclosporin), the agency said in a "complete response" letter announced Aug. 4

FDA Says Lux's Uveitis Treatment Luveniq Needs Another Clinical Trial

Lux Biosciences will have to do another clinical trial - on top of three already completed Phase III studies - for FDA to consider approving its uveitis treatment Luveniq (voclosporin), the agency said in a "complete response" letter announced Aug. 4

FDA Says Lux's Uveitis Treatment Luveniq Needs Another Clinical Trial

In a "complete response" letter following the last-minute cancellation of an advisory committee review in June, FDA asks the biotech to do an additional confirmatory study.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS070608

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