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News

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
Jul 10, 2019

Launch of Smyraf® Tablets - Provides a new therapeutic option for rheumatoid arthritis in patients who have an inadequate response to conventional therapies -

TOKYO, July 10, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced the launch of the Smyraf® 50 mg and 100 mg Tablets (generic...

Read more about Launch of Smyraf® Tablets - Provides a new therapeutic option for rheumatoid arthritis in patients who have an inadequate response to conventional therapies -
Jun 26, 2019

Astellas Named to FTSE4Good Index Series for the Eighth Consecutive Year

Tokyo, June 26, 2019 - Astellas Pharma Inc. (President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that it has been named to the FTSE4Good Index Series for the eighth...

Read more about Astellas Named to FTSE4Good Index Series for the Eighth Consecutive Year
Jun 18, 2019

HYPERCHOLESTEROLEMIA DRUG REPATHA® SC INJECTION RECEIVES SUPPLEMENTAL INDICATION APPROVAL AS MONOTHERAPY FOR TREATING HYPERCHOLESTEROLEMIA PATIENTS NOT SUITABLE FOR STATIN THERAPY

TOKYO (June 18, 2019) –, Amgen Astellas BioPharma K.K. (Headquarters, Tokyo; President and Representative Director: Steve Sugino, “Amgen Astellas”) and Astellas Pharma Inc. (Headquarters,...

Read more about HYPERCHOLESTEROLEMIA DRUG REPATHA® SC INJECTION RECEIVES SUPPLEMENTAL INDICATION APPROVAL AS MONOTHERAPY FOR TREATING HYPERCHOLESTEROLEMIA PATIENTS NOT SUITABLE FOR STATIN THERAPY
Jun 17, 2019

Launch of Gonax® 240 mg (New dosage form) in Japan for the treatment of prostate Cancer

TOKYO, June 17, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that it launched Gonax® 240 mg (generic name: degarelix acetate, “

Read more about Launch of Gonax® 240 mg (New dosage form) in Japan for the treatment of prostate Cancer
Jun 7, 2019

Bisono® Tape 2 mg, a Transdermal Patch of β1 Blocker, Launched in Japan

Tokyo: June 7, 2019 - TOA EIYO Ltd. (President: Atsuo Takahashi, Ph.D., “TOA EIYO”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced...

Read more about Bisono® Tape 2 mg, a Transdermal Patch of β1 Blocker, Launched in Japan
Jun 4, 2019

Astellas and Seattle Genetics Announce Antibody-Drug Conjugate Enfortumab Vedotin Produced Tumor Response Rate of 44 Percent in Patients with Most Common Type of Advanced Urothelial (Bladder) Cancer

-First Investigational Therapy in a Pivotal Trial to Address Unmet Need for Patients with Advanced Urothelial Cancer After Treatment with Platinum Chemotherapy and a PD-1 or PD-L1 Inhibitor-

TOKYO and BOTHELL, Wash., June 3, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that...

Read more about Astellas and Seattle Genetics Announce Antibody-Drug Conjugate Enfortumab Vedotin Produced Tumor Response Rate of 44 Percent in Patients with Most Common Type of Advanced Urothelial (Bladder) Cancer
May 30, 2019

U.S. FDA Approves Supplemental New Drug Application Adding Overall Survival Data for XOSPATA® (gilteritinib)

- Phase 3 ADMIRAL trial showed patients treated with XOSPATA demonstrated longer Overall Survival than those who received salvage chemotherapy1 -

TOKYO – May 30, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) approved a...

Read more about U.S. FDA Approves Supplemental New Drug Application Adding Overall Survival Data for XOSPATA® (gilteritinib)
May 10, 2019

Partial Amendments to the Articles of Incorporation

Read more about Partial Amendments to the Articles of Incorporation
May 10, 2019

Revision of Remuneration System for Directors

Read more about Revision of Remuneration System for Directors
May 10, 2019

Notice Regarding the Performance-linked Stock Compensation Scheme

Read more about Notice Regarding the Performance-linked Stock Compensation Scheme
Apr 25, 2019

Astellas Announces Cancellation of Treasury Shares

Read more about Astellas Announces Cancellation of Treasury Shares
Apr 25, 2019

Changes of Representative Director and Directors

Changes of Representative Director and Directors

Read more about Changes of Representative Director and Directors
Apr 1, 2019

Phase 3 ADMIRAL Trial Data Show XOSPATA® (gilteritinib) Significantly Prolongs Overall Survival in Adult Patients with FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia -Study results will be presented at AACR2019-

TOKYO – April 1, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) today announced results from the Phase 3 ADMIRAL clinical trial comparing...

Read more about Phase 3 ADMIRAL Trial Data Show XOSPATA® (gilteritinib) Significantly Prolongs Overall Survival in Adult Patients with FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia -Study results will be presented at AACR2019-
Mar 28, 2019

Seattle Genetics and Astellas Announce Positive Topline Results from Pivotal Trial of Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer - Companies Plan to Submit Biologics License Application Later This Year –

BOTHELL, Wash. and TOKYO, Mar 28, 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 Positive Topline Results from Pivotal Trial of Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer - Companies Plan to Submit Biologics License Application Later This Year –
Mar 26, 2019

Oral JAK Inhibitor Smyraf® Tablets Approved in Japan for the Treatment of Rheumatoid Arthritis (including prevention of structural joint damage) in Patients Who Have an Inadequate Response to Conventional Therapies

TOKYO, March 26, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that Smyraf® 50 mg and 100 mg Tablets (generic name:...

Read more about Oral JAK Inhibitor Smyraf® Tablets Approved in Japan for the Treatment of Rheumatoid Arthritis (including prevention of structural joint damage) in Patients Who Have an Inadequate Response to Conventional Therapies

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