Keeping Track: Orphans Headline FDA Approvals; Gene Therapies Stand Out Among Submissions
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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UCB’s zilucoplan for treating gMG is among the latest new drugs that the European Medicines Agency has started reviewing for potential EU marketing approval.
The FGFR inhibitor beats prior entrants on efficacy in cholangiocarcinoma, although Relay presented data at ESMO for its investigational RLY-4008 showing especially high efficacy and tolerability.
The Dutch firm’s US filing for its first-in-class PI3K inhibitor has been accepted under priority review, bringing the asset closer to becoming the first disease-modifying option for a rare, genetic disorder.