The US Food and Drug Administration's withdrawal of Covis Pharma's preterm birth prevention drug Makena seems increasingly inevitable following the 20 January endorsement of pulling the accelerated approval by Celia Witten, deputy director of the Center for Biologics Evaluation and Research.
Witten’s recommendation adds to the strong 14-1 FDA advisory committee vote in October against keeping Makena on the market while another confirmatory study is conducted. Witten served as the presiding officer over that three-day meeting
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?