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Marinus Pharmaceuticals, Inc.

http://marinuspharma.com/

Latest From Marinus Pharmaceuticals, Inc.

EU Accelerated Assessment: Lilly Requests Fast-Track Status, EMA Says No To SIFI And Janssen

Eli Lilly has asked the European Medicines Agency to grant accelerated assessment to its planned EU marketing application for pirtobrutinib. Meanwhile, the agency has rejected requests to fast-track SIFI’s Akantior and Janssen’s Zejula plus Zytiga combination therapy. 

European Performance Tracker Review Pathway

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.

European Performance Tracker Review Pathway

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.

Rare Diseases Launches

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

Approvals US FDA Performance Tracker
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