Keeping Track, Oncology Edition: Biologic Breakthroughs And BLAs
The latest oncology development news and highlights from our US FDA Performance Tracker.
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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.
CBER is starting the year with four novel gene and cell therapy applications under review and rolling submissions underway for more.