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Month Year

Jan 31, 2024

Astellas Submits Supplemental New Drug Application in Japan for PADCEV^TM (enfortumab vedotin (genetical recombination) with KEYTRUDA^® (pembrolizumab (genetical recombination)) for First-Line Treatment of Advanced Bladder Cancer

– Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival vs platinum-containing chemotherapy–

TOKYO – January 31, 2024 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced the submission of a Supplemental New Drug Application (sNDA) on January 31 to Japan's Ministry of Health, Labour and Welfare (MHLW) for PADCEV™ (enfortumab vedotin...

Read more about Astellas Submits Supplemental New Drug Application in Japan for PADCEV^TM (enfortumab vedotin (genetical recombination) with KEYTRUDA^® (pembrolizumab (genetical recombination)) for First-Line Treatment of Advanced Bladder Cancer
Jan 26, 2024

European Medicines Agency Validates Type II Variation Application for PADCEV^TM (enfortumab vedotin) with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

– Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival –

TOKYO and NEW YORK.– Jan. 26, 2024 – Astellas Pharma Inc. (TSE:4503,President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced that on Jan. 26, 2024 the European Medicines Agency (EMA) validated for review a Type II variation application for PADCEVTM (enfortumab vedotin)...

Read more about European Medicines Agency Validates Type II Variation Application for PADCEV^TM (enfortumab vedotin) with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
Jan 8, 2024

Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.

TOKYO, January 8, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the U.S. Food and Drug Administration (FDA) issued a complete response letter on January 4, 2024, regarding the Biologics License Application (BLA) for zolbetuximab, an investigational agent...

Read more about Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.
Dec 28, 2023

Elpiscience and Astellas Enter into Research Collaboration and License Agreement for Novel Bispecific Macrophage Engager

Shanghai and Suzhou, TOKYO, December 28, 2023 - Elpiscience Biopharma, Ltd. (Chairman and CEO: Darren Ji, MD, Ph.D., “Elpiscience”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced a research collaboration and license agreement for novel bispecific...

Read more about Elpiscience and Astellas Enter into Research Collaboration and License Agreement for Novel Bispecific Macrophage Engager
Dec 22, 2023

Astellas Completes Acquisition of Propella Therapeutics

TOKYO, December 22, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) announced today that it has completed the acquisition of Propella Therapeutics, Inc. (President and CEO: William Moore, “Propella”), and has become a wholly owned subsidiary of Astellas...

Read more about Astellas Completes Acquisition of Propella Therapeutics

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