Sep, 2023

U.S.A.
News / Therapeutic Area News
European Medicines Agency Validates Type II Variation for Astellas' XTANDI® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
Application based on results from Phase 3 EMBARK trial, which showed XTANDI plus leuprolide reduced risk of metastasis or death by 58% TOKYO, Sept. 12, 2023 /PRNewswire/ -- Astellas Pharma Inc....
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Aug, 2023

U.S.A.
News / Therapeutic Area News
FDA Grants Priority Review for XTANDI® in Non-Metastatic Castration-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
If approved, XTANDI would become the first and only novel hormone therapy approved in this earlier type of prostate cancer NEW YORK and TOKYO, Aug. 23, 2023 /PRNewswire/ -- Pfizer Inc. (NYSE: PFE)...
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U.S.A.
News / Therapeutic Area News
European Medicines Agency Accepts Iveric Bio's Marketing Authorization Application for Avacincaptad Pegol for Geographic Atrophy
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), today announced the European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization...
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U.S.A.
News / Therapeutic Area News
Astellas to Open New Life Sciences Facility in DivcoWest's Cambridge Crossing Neighborhood
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and DivcoWest, a DivCore Capital Company, announced today plans for Astellas to open a new state-of-the-art life...
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U.S.A.
News / Therapeutic Area News
China's National Medical Products Administration Accepts Astellas' Biologics License Application for Zolbetuximab
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration...
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