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Astellas is committed to providing timely and accurate information about our business, science and products. This section offers global resources for investors, journalists and media professionals. News and resources from our local affiliates can be viewed in the Local news section. If you are not an investor or journalist, click here.

Month Year

Jul 29, 2024

Astellas Receives Positive CHMP Opinion for PADCEV^TM (enfortumab vedotin) in combination with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

- If approved, enfortumab vedotin in combination with pembrolizumab will be the first and only treatment to offer an alternative to platinum-containing chemotherapy, the current standard of care for those with unresectable or metastatic urothelial cancer

TOKYO, July 26, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency...

Read more about Astellas Receives Positive CHMP Opinion for PADCEV^TM (enfortumab vedotin) in combination with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
Jul 26, 2024

Astellas Receives Positive CHMP Opinion for Zolbetuximab in Combination with Chemotherapy for Treatment of Advanced Gastric and Gastroesophageal Junction Cancer

- If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2-targeted therapy approved in the European Union

TOKYO, July 26, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that on July 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European...

Read more about Astellas Receives Positive CHMP Opinion for Zolbetuximab in Combination with Chemotherapy for Treatment of Advanced Gastric and Gastroesophageal Junction Cancer
Jul 22, 2024

Astellas and Graduate School of Medicine / Faculty of Medicine, Osaka University Enter into Research Collaboration to Develop Pluripotent Stem Cell-Derived Cartilage Organoid Cell Therapy

- Collaborative Research on Innovative Cartilage Organoid Cell Therapy for Intervertebral Disc Degenerative Disease using Astellas’ Universal Donor Cell Technology -

TOKYO and Osaka, July 22, 2024 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Graduate School of Medicine / Faculty of Medicine, Osaka University (President: Shojiro Nishio “Osaka University”) today announced...

Read more about Astellas and Graduate School of Medicine / Faculty of Medicine, Osaka University Enter into Research Collaboration to Develop Pluripotent Stem Cell-Derived Cartilage Organoid Cell Therapy
Jul 2, 2024

China’s National Medical Products Administration Approves XTANDI^® (enzalutamide) in Metastatic Hormone-Sensitive Prostate Cancer

- Approval marks XTANDI’s third indication for advanced prostate cancer in China -

TOKYO, July 2, 2024 – 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 (NMPA) has approved...

Read more about China’s National Medical Products Administration Approves XTANDI^® (enzalutamide) in Metastatic Hormone-Sensitive Prostate Cancer
May 30, 2024

U.S. FDA ACKNOWLEDGES ASTELLAS’ RESUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR ZOLBETUXIMAB AND SETS NEW ACTION DATE

If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and gastroesophageal junction cancers as the first and only CLDN18.2-targeted therapy in the U.S.

TOKYO, May 30, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the company’s resubmission of the Biologics License Application (BLA) for zolbetuximab...

Read more about U.S. FDA ACKNOWLEDGES ASTELLAS’ RESUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR ZOLBETUXIMAB AND SETS NEW ACTION DATE

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