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As for safety, 85% had at least one Grade 3 or higher treatment-emergent adverse event (TEAE). According to GlobalData’s analyst consensus forecast, global sales for ziftomenib will reach $255m by 2029. It received fast track and breakthrough designation from the FDA and is poised to be first to market.
In December 2014, Amgen’s landmark FDA approval saw Blincyto (blinatumomab) approved for relapsed/refractory (R/R) B-cell progenitor acute lymphoblastic leukaemia (B-ALL), at the time being the only marketed BiTE. Currently, there are 110 BiTEs in oncology clinical trials, with seven in Phase III and three in pre-registration. months vs. 4.0
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billion by 2029. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021.
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