Keeping Track: Orphans Headline FDA Approvals; Gene Therapies Stand Out Among Submissions
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
You may also be interested in...
A Standard September Ahead Thanks To Light US FDA User Fee Calendar With Few Expedited Reviews
Twelve applications with September goal dates include six novel agents but only one breakthrough designation.
Cool Down: US FDA’s July User Fee Calendar Suggests Slower Pace After Torrid June
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.
New EU Filings Include First Self-Administered Treatment For Myasthenia Gravis
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.