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US FDA Performance Tracker Cancer Drug Review

Keeping Track, Oncology Edition: Biologic Breakthroughs And BLAs

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Executive Summary

The latest oncology development news and highlights from our US FDA Performance Tracker.

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Keeping Track: US FDA Receives Advanced Biologic BLAs From ImmunityBio, CSL; Nymox, Medac Stumble

The latest NDA and BLA submission news and highlights from the Pink Sheet’s US FDA Performance Tracker

Endpoint Milestone In AML: Kronos’ Entospletinib Trial Will Rely On Residual Disease

Phase III study in newly diagnosed patients with NPM1-mutated AML could enable Kronos’ SYK-inhibitor to reach market two years earlier under accelerated approval than it would under a traditional endpoint, company says.

Keeping Track: Oncology Submissions From Blueprint, Y-mAbs, BMS/bluebird; Approvals For BMS’ Reblozyl, LFB’s SevenFact

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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