Keeping Track: Regeneron Wins US FDA OK For Evkeeza, New Libtayo Uses; G1 Cosela Cleared
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
You may also be interested in...
Leo’s Tralokinumab Among 11 New Approval Hopefuls In EU
The developers of eleven new drugs could learn this week whether the European Medicines Agency will set them on course for pan-EU marketing approval.
Keeping Track: Cloudy Horizon For Teplizumab, Roxadustat; Nuplazid Stumbles Over Subgroups; CAR-T Submissions From Gilead, J&J
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Pivotal Moment In EU For Potential New Drugs
Decisions are due on several EU marketing applications at the March meeting of the European Medicines Agency’s drug evaluation committee, the CHMP. Also, a number of companies might be asked to address outstanding issues the CHMP has about products they want to market that are near the final stages of review.