News Releases

Click here to access press releases from Astellas Pharma Inc. located in Tokyo, Japan.

Month Year

Month Year

Dec 2, 2019

Seattle Genetics and Astellas Announce Clinical Trial Collaboration with Merck to Evaluate Enfortumab Vedotin in Combination with KEYTRUDA® (pembrolizumab) in Patients with Metastatic Urothelial Cancer

- Companies to Initiate Phase 3 Trial to Support Global Registrations -
Nov 25, 2019

Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA)

Approval based on Asian PREVAIL study of men with metastatic castration-resistant prostate cancer
Oct 31, 2019

New England Journal of Medicine Publishes Results from Astellas' Phase 3 ADMIRAL Trial of XOSPATA® (gilteritinib) in Adult Patients with FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia(1)

- Results were published online and in the October 31 print edition of the Journal -
Oct 28, 2019

U.S. FDA Grants Fast Track Designation to Astellas for the Development of ASP1128 for Patients at Risk for Acute Kidney Injury
Oct 28, 2019

Astellas Oncology Announces Grand Prize Winner of 2019 C3 Prize® to Improve Cancer Care

- Four innovators awarded $200,000 in total grants and resources following live pitch event to a panel of judges that included celebrity entrepreneur Bill Rancic -
- Photos 1
Oct 25, 2019

European Commission Approves Astellas' XOSPATA™ (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

Approval follows accelerated assessment, orphan designation by European Medicines Agency
Oct 10, 2019

Astellas earns spot on Working Mother's Best Companies for Dads List
Oct 1, 2019

Astellas Commits Nearly $13 Million to Fund Boston-Area Start-Up Innovation in Cell and Gene Therapy

Financial Support for LabCentral Incubators Builds on Astellas' $1 Billion+ Investment in Boston's Life Science Community
Sep 30, 2019

Astellas Oncology Announces 2019 C3 Prize® Finalists

- Finalists will present their ideas during a live pitch event
Sep 28, 2019

Seattle Genetics and Astellas Announce Results from Phase 1 Trial of Investigational Agent Enfortumab Vedotin in Combination with Immune Therapy Pembrolizumab as First-Line Treatment for Advanced Bladder Cancer

- Study Met Outcomes for Safety and 71 Percent of Patients with Locally Advanced or Metastatic Urothelial (Bladder) Cancer Had a Confirmed Response -
Sep 24, 2019

Astellas ranks in Top 10 of Working Mother Best Companies list

- Astellas named Working Mother "100 Best Company" for fifth consecutive year -
Sep 20, 2019

Astellas Receives Positive CHMP Opinion for XOSPATA® (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

If approved by the European Commission, gilteritinib would represent one of the few advances in Europe for AML over the past 40 years(1)
Sep 20, 2019

Evrenzo® (roxadustat) Tablets Approved in Japan for the Treatment of Anemia Associated with Chronic Kidney Disease in Dialysis Patients
Sep 18, 2019

Astellas Celebrates Decade of Service by Volunteering 80,000 Hours to Help Local Communities

- US Employees Support 16 Local Organizations for Changing Tomorrow Day 2019 -
- Photos 3
Sep 16, 2019

Seattle Genetics and Astellas Announce U.S. 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 -
Sep 11, 2019

Astellas Partners with MBC BioLabs to Help Pioneering Biotech Start-ups Accelerate Early Drug Discovery and Research Efforts

Supporting pre-clinical scientific research: "Golden Ticket" sponsorship provides access to life-science incubator and in-house Astellas expertise for scientific entrepreneurs with cutting-edge ideas
Aug 27, 2019

Astellas Announces Key Leadership Appointments within Oncology and Patient Centricity Organizations
- Photos 2
Aug 21, 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
Aug 6, 2019

Astellas Announces Appointment of David Fryrear as New Global Head of Clinical and Research Quality Assurance Organization
- Photos 1
Aug 5, 2019

Astellas Initiates Phase 3 Clinical Trials for Fezolinetant in Postmenopausal Women with Vasomotor Symptoms
Jul 16, 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-
Jul 10, 2019

Astellas Appoints Chelsea Glinski as National Vice President Oncology Sales

Glinski to Oversee US Sales for XTANDI
- Photos 1
Jun 3, 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-
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 chemotherapy[1] -
May 20, 2019

Astellas Oncology Announces C³ Prize® Call for Entries to Award $200,000 to the Best Ideas in Cancer Care Beyond Medicine

-Total Funds To Be Awarded Increased to $200,000; All Encouraged to Apply -
May 9, 2019

Astellas' Chelsea Glinski Named a 2019 Healthcare Businesswomen's Association Luminary
- Photos 1
May 5, 2019

New Data Show Mirabegron Reduced OAB Symptoms in Men with Benign Prostatic Hyperplasia Currently Treated with Tamsulosin

- Data Presented at the American Urological Association 2019 Annual Meeting -
Apr 25, 2019

Astellas Statement on U.S. Department of Justice Settlement Related to Patient Co-Pay Assistance Foundations
Apr 3, 2019

Astellas Announces Key Senior Leadership Promotions and New Hire in Medical and Development Organization
- Photos 3
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 Compared with Salvage Chemotherapy

- Study results will be presented at American Association for Cancer Research Annual Meeting 2019 -
Mar 28, 2019

Astellas: Five Consecutive Years of Perfect Equality Scores
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 -
Mar 26, 2019

Astellas Presents Fezolinetant Phase 2b Clinical Trial Results at Endocrine Society's Annual Meeting (ENDO)

- Investigational compound fezolinetant reduced frequency and severity of vasomotor symptoms in postmenopausal women -
Mar 18, 2019

Astellas Launches PROGRAF® Granules (tacrolimus for oral suspension) in the U.S. for Pediatric Liver, Heart, and Kidney Transplant Patients
- Photos 1
Feb 28, 2019

Astellas Announces Key Leadership Promotions and New Hire in Legal, IP and Immuno-Oncology
Feb 20, 2019

Astellas and WiserCare Announce Collaboration to Improve Patient Experience

Joint Project Will Explore Enhancements to Patient Communication and Shared Decision-Making
Feb 11, 2019

Phase 3 ARCHES Trial Shows XTANDI® (enzalutamide) Significantly Improved Radiographic Progression-Free Survival in Men with Metastatic Hormone-Sensitive Prostate Cancer

Data to be presented at the 2019 Genitourinary Cancers Symposium
Jan 10, 2019

Astellas Announces Key Senior Leadership Promotions and New Hire in Medical and Development Organization
- Photos 4
Dec 20, 2018

Astellas and Pfizer Announce Positive Top-Line Results from Phase 3 ARCHES Trial of XTANDI® (enzalutamide) in Men with Metastatic Hormone-Sensitive Prostate Cancer
Dec 14, 2018

Astellas Acquires Potenza Therapeutics

Acquisition adds clinical stage novel immuno-oncology programs to Astellas' oncology pipeline
- Photos 1
Dec 12, 2018

Astellas Promotes Lei Ding to vice president, Payer Strategy, Contracts, and Pricing
- Photos 1
Dec 10, 2018

Astellas Launches XOSPATA® (gilteritinib) in the U.S. for the Treatment of Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation
Dec 3, 2018

Astellas Presents Updated Results from Phase 1 Study of Gilteritinib Plus Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)
Nov 28, 2018

XOSPATA® (gilteritinib) Approved by U.S. FDA for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation

- FLT3 mutation-positive AML is a life-threatening disease[1] with significant unmet medical needs -
Nov 20, 2018

Astellas Global Health Foundation Launches - Foundation to Support Improving Access to Health for Underserved Populations -
Nov 20, 2018

Astellas US LLC and the Academy of Oncology Nurse & Patient Navigators (AONN+) Announce Collaboration

Navigation Acuity Tool to be Developed by Astellas US LLC and AONN+
Nov 19, 2018

Astellas to Present New Data on Gilteritinib in Multiple Populations of FLT3 Mutation-Positive Acute Myeloid Leukemia (AML) Patients at the 2018 American Society of Hematology (ASH) Annual Meeting

- Abstracts include updated results from Phase 1 study of gilteritinib in patients with newly diagnosed AML -
Nov 12, 2018

Astellas Appoints Eloiza Domingo-Snyder to Head of Diversity and Inclusion
- Photos 1
Oct 9, 2018

Astellas Details Progress and Commitment to Patients and the Community in the Company's Americas 2017 Corporate Social Responsibility Report Card
- Photos 1
Oct 4, 2018

Astellas Oncology Announces Grand Prize Winner of C3 Prize® at Union for International Cancer Control (UICC) World Cancer Congress

Three innovators working to change cancer care awarded a combined $100,000 in grants following live pitch to a panel of judges that included celebrity entrepreneur Bill Rancic
- Photos 1

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