UCB S.A.'s hopes of launching Bimzelx in the US this year have been scuppered again by regulators across the Atlantic who have rejected the potential blockbuster for inflammatory diseases, citing facility inspection issues.
UCB Rocked By US FDA Rejection Of Blockbuster-In-Waiting Bimzelx
Agency Cites Facility Inspection Concerns With Psoriasis Filing
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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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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