EU Accelerated Assessment Tracker
Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.
You may also be interested in...
Tislelizumab & Tremelimumab Among Latest Filings In EU
The sponsors of two monoclonal antibody products, tislelizumab and tremelimumab, are each seeking marketing approval for more than one indication.
Marinus, With Ztalmy Approval, Takes First Step Into Seizure Disorder Market
The company will launch Ztalmy for an ultra-rare pediatric seizure disorder but hopes to expand to larger indications in the future. CEO Scott Braunstein talks to Scrip about the launch.
Keeping Track: Marinus’ Ztalmy Continues US FDA’s Orphan Streak; AZ Gets Adjuvant Nod For Lynparza, Fasenra CRL
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker