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U S FDA Approves Supplemental New Drug Application for Takeda s ICLUSIG® (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML

Takeda Pharmaceutical Company Limited U.S. FDA Approves Supplemental New Drug Application for Takeda’s ICLUSIG® (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML Saturday, December 19, 2020 2:19PM IST (8:49AM GMT)    – Updated ICLUSIG Label will Prove Practice-Changing, Expanding Indication to CP-CML Patients with Resistance or Intolerance to At Least Two Prior Tyrosine Kinase Inhibitors (TKIs) – ­– Approval Based on Data from the Phase 2 OPTIC Trial, Which Evaluated Response-Based ICLUSIG Dosing Regimens in CP-CML – – New Dosing Regimen in CP-CML Optimizes Benefit-Risk Profile, Providing Efficacy and Improving Safety –    Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG

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