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UCB Holds Breath Amid Concerns Of Second FDA Rejection Of Bimzelx

Agency Has Questions After Inspection

 
• By Kevin Grogan

The US Food and Drug Administration has published a report after an inspection of UCB’s Belgian facility where Bimzelx is manufactured and the findings suggest that a long-awaited approval for the psoriasis drug should not be taken for granted.

UCB
• Source: UCB

Anyone who thought that US approval at the second time of asking for UCB S.A.'s Bimzelx was a mere formality will have read the Food and Drug Administration's latest facility inspection report with some alarm.

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