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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Twelve applications with September goal dates include six novel agents but only one breakthrough designation.
FDA action is expected on a handful of novel agents, including Daiichi Sankyo’s quizartinib, and conversion to full approval for Eisai/Biogen’s Leqembi.
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.