Oct, 2019

U.S.A.
News / Therapeutic Area News
U.S. FDA Grants Fast Track Designation to Astellas for the Development of ASP1128 for Patients at Risk for Acute Kidney Injury
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the...
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U.S.A.
News / Therapeutic Area News
European Commission Approves Astellas' XOSPATA™ (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that the European Commission (EC) has approved the oral once-daily therapy XOSPATA™...
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Sep, 2019

U.S.A.
News / Therapeutic Area News
Astellas Receives Positive CHMP Opinion for XOSPATA® (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...
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Sep, 2018

U.S.A.
News / Therapeutic Area News
Astellas Receives Positive CHMP Opinion for XTANDI® (enzalutamide) for Adult Men with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...
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Aug, 2018

U.S.A.
News / Therapeutic Area News
Pfizer and Astellas Amend Clinical Research Protocols for Two Phase 3 Trials of Enzalutamide in Patients with Hormone-Sensitive Prostate Cancer
Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced amendments to the protocols for two registrational Phase 3...
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