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.
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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.
The sprawling safety surveillance system is propelling advances in informatics and advanced analytics, but the agency is delaying next contracting cycle to digest its experience.
AstraZeneca’s Truqap and Evive’s Ryzneuta bring FDA center for drugs’ 2023 novel agent total to 51, while biologics center already sits on a record-breaking 14 novel approvals.