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TOKYO, April12, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it expects to book approximately ¥70.0 billion in the fourth quarter of fiscal year 2023 for an impairment loss for intangible assets and change in fair value of contingent consideration...
TOKYO, April 1, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced it received notification from the U.S. Food and Drug Administration (FDA) of acceptance of the company’s supplemental New Drug Application (sNDA) to include positive...
TOKYO, March 28, 2024 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that on March 27, 2024 the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the supplemental Biologics License Application (sBLA) for...
TOKYO, March 26, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that on March 26, 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved VYLOY™ (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody for patients...
Read more about Astellas’ VYLOYTM (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer
TOKYO, March 22, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XTANDITM (enzalutamide) as monotherapy...
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