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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

Month Year

Sep 17, 2019

Seattle Genetics and Astellas Announce US FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer

- Food & Drug Administration Sets Prescription Drug User Fee Action Date for March 15, 2020 -

BOTHELL, Wash. and TOKYO, September 16, 2019 – Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced...

Read more about Seattle Genetics and Astellas Announce US FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer
Sep 13, 2019

Astellas and iota Biosciences Enter into Collaborative Research and Development Agreement -Companies to explore new biosensing and treatment measures using ultra-small implantable medical devices-

TOKYO and Berkeley, CA., September 13, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) and Iota Biosciences, Inc. (Co-founders and Co-CEOs:...

Read more about Astellas and iota Biosciences Enter into Collaborative Research and Development Agreement -Companies to explore new biosensing and treatment measures using ultra-small implantable medical devices-
Sep 2, 2019

RIKEN and Astellas Enter into Worldwide Exclusive Licensing Agreement for Artificial Adjuvant Vector Cell Technology in Oncology

Saitama and Tokyo, September 2, 2019 - RIKEN (President: Hiroshi Matsumoto, Ph.D.) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today...

Read more about RIKEN and Astellas Enter into Worldwide Exclusive Licensing Agreement for Artificial Adjuvant Vector Cell Technology in Oncology
Aug 22, 2019

U.S. FDA Grants XTANDI® (enzalutamide) Application Priority Review for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer

XTANDI Supplemental New Drug Application (sNDA) Seeks to Add an Indication for Men with Prostate Cancer that Has Spread but Is Sensitive to Hormone Therapy

TOKYO and NEW YORK, August 21, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and...

Read more about U.S. FDA Grants XTANDI® (enzalutamide) Application Priority Review for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer
Aug 9, 2019

Yokohama City University, Tokyo University of the Arts and Astellas Launched Health Mock Lab. to Create New Digital Healthcare Solutions Using Gamification

TOKYO, August 9, 2019 - Yokohama City University (Kanagawa, Chairperson of the Board of Trustees and CEO: Yoshiyuki Futami, “YCU”) , Tokyo University of the Arts (Tokyo, President: Kazuki...

Read more about Yokohama City University, Tokyo University of the Arts and Astellas Launched Health Mock Lab. to Create New Digital Healthcare Solutions Using Gamification
Aug 6, 2019

Astellas Initiates Phase 3 Clinical Trials for Fezolinetant in Postmenopausal Women with Vasomotor Symptoms

TOKYO, August 6, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced dosing of the first patient in the SKYLIGHT 1™ Phase 3 pivotal...

Read more about Astellas Initiates Phase 3 Clinical Trials for Fezolinetant in Postmenopausal Women with Vasomotor Symptoms
Jul 30, 2019

Astellas Submits Supplemental New Drug Application for Approval of Additional Indication of XTANDI® for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer in Japan

TOKYO, July 30, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that it has submitted a supplemental new drug application for the...

Read more about Astellas Submits Supplemental New Drug Application for Approval of Additional Indication of XTANDI® for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer in Japan
Jul 24, 2019

Astellas Announces Acceptance by the European Medicines Agency of a Variation Application for Regulatory Review for Use of XTANDITM (enzalutamide) in metastatic Hormone-Sensitive Prostate Cancer

TOKYO AND CHERTSEY, July 24 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced the acceptance by the European Medicines Agency (EMA) of a Type...

Read more about Astellas Announces Acceptance by the European Medicines Agency of a Variation Application for Regulatory Review for Use of XTANDITM (enzalutamide) in metastatic Hormone-Sensitive Prostate Cancer
Jul 17, 2019

Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer

-Submission Based on Pivotal Phase 2 Trial Results Recently Presented at Annual Meeting of American Society of Clinical Oncology-

TOKYO and BOTHELL, Wash., July 16, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seattle Genetics, Inc. (Nasdaq:SGEN) today announced...

Read more about Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer
Jul 17, 2019

Astellas and Frequency Therapeutics Enter into License Agreement for FX-322, a Regenerative Treatment Candidate for Hearing Loss

Astellas Obtains the Exclusive Rights to Develop and Commercialize FX-322 in Ex-US Markets; Frequency Retains U.S. Rights

TOKYO and WOBURN, Mass., July 17, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) and Frequency Therapeutics, Inc. (CEO: David Lucchino,...

Read more about Astellas and Frequency Therapeutics Enter into License Agreement for FX-322, a Regenerative Treatment Candidate for Hearing Loss

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