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.
UCB Holds Breath Amid Concerns Of Second FDA Rejection Of Bimzelx
Agency Has Questions After Inspection
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.
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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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