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UCB Rocked By US FDA Rejection Of Blockbuster-In-Waiting Bimzelx

Agency Cites Facility Inspection Concerns With Psoriasis Filing

Executive Summary

The Belgian group’s US launch of Bimzelx could be delayed by up to a year after the FDA hit UCB with a complete response letter which states that "certain pre-approval inspection observations must be resolved” before the drug can get the green light for psoriasis.

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