UCB Holds Breath Amid Concerns Of Second FDA Rejection Of Bimzelx
Agency Has Questions After Inspection
Executive Summary
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.
You may also be interested in...
UCB Awaits Two Regulatory Verdicts For Bimzelx
An EU decision in hidradenitis suppurativa is important, but the long-delayed US decision in psoriasis – and the specifics of the label – is even more so.
Are US Delays Accumulating For UCB?
UCB dampens hopes for US FDA action this year on long-delayed bimekizumab, while zilucoplan looks to have missed its goal date.
Cool Down: US FDA’s July User Fee Calendar Suggests Slower Pace After Torrid June
FDA action is expected on a handful of novel agents, including Daiichi Sankyo’s quizartinib, and conversion to full approval for Eisai/Biogen’s Leqembi.