Keeping Track: Marinus’ Ztalmy Continues US FDA’s Orphan Streak; AZ Gets Adjuvant Nod For Lynparza, Fasenra CRL
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Keeping Track: Pediatric Approvals, Seres Starts C Diff Submission, And BMS Pulls Reblozyl sBLA Before Possible CRL
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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.
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.