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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AstraZeneca’s Fasenra Future Weakened By Pivotal Eosinophilic Esophagitis Trial Flop
The major’s monoclonal antibody drug missed one of two primary endpoints in a late-stage eosinophilic esophagitis trial in the second setback this year to plans for label expansion beyond the asthma maintenance setting.
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.