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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.

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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.

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