Are US Delays Accumulating For UCB?
Executive Summary
UCB dampens hopes for US FDA action this year on long-delayed bimekizumab, while zilucoplan looks to have missed its goal date.
You may also be interested in...
UCB Holds Breath Amid Concerns Of Second FDA Rejection Of Bimzelx
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.
US FDA’s Sentinel System Strives To Stay Ahead Of Its Own Success
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.
Keeping Track: US FDA Drugs Center Passes 50 Novel Agent Approvals In 2023
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.