News Releases

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

Month Year

Nov 16, 2020

Astellas to Present New Data on Gilteritinib in FLT3 Mutation-Positive Acute Myeloid Leukemia at the 2020 American Society of Hematology Annual Meeting

Includes five oral presentations that collectively explore the use of gilteritinib across the FLT3mut+ AML care continuum
Nov 6, 2020

XTANDI® (enzalutamide soft capsules) Approved by China NMPA for the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer

Enzalutamide is now NMPA-approved for both non-metastatic and metastatic castration-resistant prostate cancer
Oct 28, 2020

Astellas Receives U.S. FDA Fast Track Designation for ASP5354, an Investigational Near-Infrared Fluorescence Imaging Agent
- Photos 1
Oct 20, 2020

U.S. FDA Grants Fast Track Designation for ASP0367/MA-0211, a Selective PPARδ Modulator being Developed for the Treatment of Primary Mitochondrial Myopathies
Oct 19, 2020

New Roxadustat Data in Anemia of Chronic Kidney Disease to be Released at ASN Kidney Week 2020 Reimagined

42 abstracts featuring additional insights into roxadustat and anemia of chronic kidney disease to be presented
Oct 12, 2020

Astellas and Seagen Announce Positive Topline Results from Second Cohort of Patients in Phase 2 Pivotal Trial of PADCEV® (enfortumab vedotin-ejfv) in Advanced Urothelial Cancer

- Durable Responses Observed in Patients Who Had Previously Received Immunotherapy but Were Ineligible for Cisplatin in Locally Advanced or Metastatic Setting -
Oct 8, 2020

Astellas and LabCentral Announce Golden Ticket Winners - Helping Emerging Biotechs Accelerate Growth of Innovative Science

- AXONIS Therapeutics, Inc. and Tenza win a year of access to life-science incubator in Cambridge, MA and access to Astellas expertise to further their research -
Oct 1, 2020

Astellas Celebrates First-Ever Virtual Day of Service to Help Non-Profit Organizations Respond to Local Community Needs

- 11th Annual Changing Tomorrow Day Enables Employees to Support Frontline Workers in Hospitals, Homeless and Hospitalized Veterans and Others in Need -
- Photos 1
Sep 29, 2020

Astellas and MBC BioLabs Announce Golden Ticket Competition to Help Biotech Start-ups Accelerate Early Drug Discovery and Research Efforts

Sponsorship provides a year of access to MBC BioLabs' life-science incubators and in-house Astellas expertise for scientific innovators
Sep 28, 2020

Astellas' Real-World Evidence Studies Provide Further Insight into Negative Impacts of Vasomotor Symptoms (VMS) Associated with Menopause

New findings to be presented at The North American Menopause Society (NAMS) 2020 Virtual Annual Meeting
Sep 23, 2020

Astellas Establishes Global Patient Centricity Leadership Structure to Incorporate Patient Perspectives Across Research and Development Continuum
- Photos 1
Sep 18, 2020

Astellas and Seattle Genetics Announce PADCEV® (enfortumab vedotin-ejfv) Significantly Improved Overall Survival in Phase 3 Trial in Previously Treated Locally Advanced or Metastatic Urothelial Cancer

- Trial Stopped Early Due to Positive Results at Planned Interim Analysis -
Sep 15, 2020

Astellas Ranks Among Top Companies for Working Parents
Sep 1, 2020

The Astellas Global Health Foundation Provides $2 Million In COVID-19 Relief To Six Organizations Serving More Than 725,000 Lives In Vulnerable Communities In Seven Countries

Recent grants and redirected funding help to respond to the COVID-19 pandemic by improving healthcare infrastructure, training and education in low-income countries
Aug 4, 2020

Astellas Oncology Opens Annual C3 Prize® Call for Entries to Award the Best Innovations in Cancer Care Beyond Medicine

-Tackling everyday challenges in cancer care, apply by September 28, 2020-
Jul 23, 2020

Astellas Partners with LabCentral to Help Emerging Biotechs Accelerate Preclinical Scientific Research

Astellas "Golden Ticket" sponsorship provides access to life-science incubator and in-house Astellas expertise for scientific entrepreneurs with cutting-edge ideas
Jul 22, 2020

Astellas is Awarded Grant from the U.S. National Institutes of Health (NIH) to Fund Early Clinical Studies of ASP8062 to Investigate Potential Novel Therapeutic Approach to Address the Opioid Crisis
Jun 8, 2020

Roxadustat Demonstrates Non-Inferiority to Darbepoetin in Phase 3 DOLOMITES Study of Anemia in Non-Dialysis-Dependent Adult Patients with Chronic Kidney Disease

- Study meets primary endpoint demonstrating non-inferiority of roxadustat to darbepoetin in correction and maintenance of hemoglobin levels
May 29, 2020

Final PROSPER Results Show XTANDI® (enzalutamide) Significantly Extends Overall Survival in Men with Non-Metastatic Castration-Resistant Prostate Cancer

Data simultaneously published in the New England Journal of Medicine and presented during the virtual scientific program of the 2020 ASCO Annual Meeting
May 29, 2020

XTANDI® (enzalutamide) Approved by Japan MHLW for the Treatment of Prostate Cancer with Distant Metastasis

XTANDI is now MHLW-approved for both metastatic hormone-sensitive prostate cancer and castration-resistant prostate cancer in Japan
May 27, 2020

FDA Approves VESIcare LS™ (solifenacin succinate) Oral Suspension for Pediatric Patients
May 20, 2020

European Medicines Agency Accepts Astellas' Marketing Authorization Application for Roxadustat

Submission for the treatment of anemia in adult patients with chronic kidney disease
Apr 30, 2020

Astellas Pharma Support Solutions Help to Address Evolving Patient Needs During COVID-19
Apr 9, 2020

Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China by the National Medical Products Administration
Feb 19, 2020

Astellas and Seattle Genetics Receive FDA Breakthrough Therapy Designation for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer

- Breakthrough Therapy Designation Based on Initial Results from Phase 1b/2 EV-103 Clinical Trial -
Feb 11, 2020

XTANDI® (enzalutamide) Demonstrates Significant Improvement in Overall Survival in Phase 3 PROSPER Trial of Patients with nmCRPC
Feb 10, 2020

Seattle Genetics and Astellas Announce Updated Results from Phase 1b/2 Trial of PADCEV™ (enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab as Investigational First-Line Treatment for Advanced Bladder Cancer

- After Median Follow-Up of 11.5 Months, 73 Percent of Patients Had Confirmed Tumor Response with Majority of Responses Still Ongoing; No New Safety Signals Observed for the Combination - - Findings To Be Presented During an Oral Session at the 2020 Genitourinary Cancers Symposium -
Feb 10, 2020

Astellas Global Health Foundation and AMPATH Announce a Three-Year $1.35 Million Grant to Aid Mental Health Programming in Western Kenya

- New Funding will Address Disparities in Mental Health Diagnosis and Treatment for 400,000 People in Need -
- Photos 1
Jan 29, 2020

Astellas Submits Supplemental New Drug Application for Approval of Evrenzo® (roxadustat) for the Treatment of Anemia Associated with Chronic Kidney Disease in Non-Dialysis Dependent Patients in Japan
Jan 21, 2020

Six Years of Perfect Equality Scores on CEI Index a Testament to Astellas' Culture of Inclusion
Jan 15, 2020

Astellas Completes Acquisition of Audentes Therapeutics

- Combined company positioned to become a global leader in AAV-based genetic medicines, with Audentes to operate as a wholly-owned subsidiary and Center of Excellence for Astellas' newly created Genetic Regulation Primary Focus
- Photos 1
Jan 8, 2020

U.S. FDA Approves Supplemental New Drug Application (sNDA) for Expanded Indication of MYCAMINE® (micafungin for injection) for the Treatment of Invasive Candidiasis in Pediatric Patients Less Than 4 Months of Age
Dec 26, 2019

Astellas Strengthens Immuno-oncology Pipeline with Acquisition of Xyphos Biosciences, Inc.

Acquisition adds talent and proprietary therapeutic platform to accelerate next-generation cancer immunotherapy
- Photos 1
Dec 18, 2019

FDA Grants Accelerated Approval to Astellas' and Seattle Genetics' PADCEV™ (enfortumab vedotin-ejfv) for People with Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer

- First-in-Class Antibody-Drug Conjugate Directed Against Nectin-4, a Protein Highly Expressed in Urothelial Tumors1,2 -
- Photos 1
Dec 16, 2019

XTANDI® (enzalutamide) Approved by U.S. FDA for the Treatment of Metastatic Castration-Sensitive Prostate Cancer

XTANDI is Now FDA-Approved for the Treatment of Metastatic Castration-Sensitive Prostate Cancer in Addition to Non-Metastatic and Metastatic Castration-Resistant Prostate Cancer
Dec 9, 2019

Astellas Announces Key Leadership Promotions in Human Resources, Legal

Catherine Levitt and Charlotte Stanton named to key global and regional senior roles
Dec 5, 2019

Astellas and MBC BioLabs Announce Golden Ticket Winners - Supporting Biotech Start-Ups to Accelerate Innovative Science

Two exciting biotechs win a year of access to life-science incubator and in-house Astellas expertise to advance their early drug discovery research
- Photos 3
Dec 2, 2019

Astellas Presents New Data on XOSPATA® (gilteritinib) in FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia at the 2019 American Society of Hematology Annual Meeting

Emerging mutations in patients with treatment resistance, from Phase 3 ADMIRAL study, will be focus of oral presentation
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)

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