News Releases

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

Month Year

Mar 21, 2023

Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab during March ASCO Plenary Series
Mar 16, 2023

Phase 3 Study Shows XTANDI® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer
- Photos 1
Mar 13, 2023

Results from Astellas' Pivotal Phase 3 SKYLIGHT 1™ Study of Fezolinetant for Vasomotor Symptoms Due to Menopause Published in The Lancet
Mar 13, 2023

Astellas Announces Phase 3 China ARCHES Study of XTANDI® Meets Primary Endpoint
Mar 9, 2023

Astellas and Seagen Announce China's National Medical Products Administration Accepts Biologics License Application for Enfortumab Vedotin in Certain Patients with Locally Advanced or Metastatic Urothelial Cancer
- Photos 1
Mar 9, 2023

Astellas and BMT CTN Announce Topline Results from Phase 3 MORPHO Trial of Gilteritinib
Feb 22, 2023

Astellas Announces Update on Preliminary Safety and Efficacy Data from FORTIS Study of Investigational AT845 in Adults with Late-Onset Pompe Disease
Feb 19, 2023

Astellas Provides Update on Fezolinetant New Drug Application in U.S.
Feb 8, 2023

Astellas Commits to Achieve Net Zero Greenhouse Gas Emissions by 2050
Feb 5, 2023

Astellas Announces Change of President and CEO and Management Structure
- Photos 2
Jan 23, 2023

Astellas Transfers MYCAMINE® Product Worldwide
Jan 20, 2023

Astellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe Disease
Jan 19, 2023

Astellas to Present Positive Findings from Phase 3 SPOTLIGHT Trial of Zolbetuximab during 2023 ASCO GI Cancers Symposium
Jan 18, 2023

Astellas Receives SBTi Approval for Revised Science-Based Climate Goals to Reduce Greenhouse Gas Emissions
Jan 9, 2023

Selecta Biosciences and Astellas Announce Exclusive Licensing and Development Agreement for Xork IgG Protease
Dec 21, 2022

Astellas, Eisai, Daiichi Sankyo and Takeda Agree to Collaborate to Reduce Environmental Burden in the Field of Pharmaceutical Packaging
Dec 20, 2022

Astellas, Seagen and Merck Announce FDA Acceptance of Supplemental Biologics License Applications for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer
Dec 15, 2022

Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 GLOW Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-negative Locally Advanced Unresectable or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers
Dec 14, 2022

The Astellas Global Health Foundation Provides $3.9 Million in Funding to Five Organizations, Supporting Key Access to Health and Community Resilience Efforts in Seven Countries
Dec 13, 2022

Astellas and MBC BioLabs Announce 2022 Future Innovator Prize Awarded to Bespoke Biotherapeutics and Cellinfinity Bio
Nov 16, 2022

Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 SPOTLIGHT Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-Negative Locally Advanced or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers
Oct 24, 2022

Astellas and Taysha Gene Therapies Announce Strategic Investment to Support Development of Taysha's AAV-based Gene Therapy Programs
Oct 11, 2022

Astellas to Present Findings from Phase 3 Long-Term Safety Study of Fezolinetant in Oral Session at The North American Menopause Society 2022 Annual Meeting
Oct 3, 2022

Astellas and Pantherna Enter into a New Technology Evaluation Agreement for Research with Expanded Target Organ to Generate mRNA-Based Regenerative Medicine Programs Using Direct Reprogramming
Sep 29, 2022

European Medicines Agency Accepts Astellas' Marketing Authorization Application for Fezolinetant
Sep 19, 2022

Astellas and MBC BioLabs Announce Astellas Future Innovator Prize to Help Biotech Start-ups Accelerate Early Drug Discovery and Research Efforts
Sep 12, 2022

Astellas, Seagen and Merck Announce Results of Clinical Trial Investigating PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) and PADCEV as Monotherapy in First-Line Advanced Urothelial Cancer
Sep 4, 2022

Astellas Announces Topline Results from Phase 3 Long-Term Safety Study of Fezolinetant in Mainland China
Aug 18, 2022

U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant
Aug 8, 2022

Astellas Oncology Announces Grand Prize Winner in Annual C3 Prize to Cultivate Innovation in Cancer Care Beyond Medicine
Aug 1, 2022

Astellas Announces Management Structure
Jul 26, 2022

Astellas and Seagen Announce Positive Topline Results For PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as First-Line Treatment for Advanced Urothelial Cancer
- Photos 1
Jul 21, 2022

Astellas Unveils Plans to Open New Biotech Campus in South San Francisco
- Photos 1
Jul 5, 2022

Mogrify and Astellas announce collaboration to conduct research on in vivo regenerative medicine approaches to address sensorineural hearing loss
- Photos 2
Jun 27, 2022

Astellas and Sutro Biopharma Announce Worldwide Strategic Collaboration to Advance Novel Immunostimulatory Antibody-Drug Conjugates (iADCs)
- Photos 1
Jun 26, 2022

Astellas Announces FDA Update on the FORTIS Clinical Trial of AT845 in Adults with Late-Onset Pompe Disease
Jun 23, 2022

Astellas Submits Fezolinetant New Drug Application to U.S. FDA
Jun 8, 2022

Astellas Celebrates the Opening of Its New Large-Scale Gene Therapy Manufacturing Facility in North Carolina
- Video 1
- Photos 1
May 31, 2022

Astellas and GO Therapeutics Enter into Strategic Research and License Agreement to Develop Novel Antibodies for Immuno-Oncology
- Photos 1
May 12, 2022

Astellas Highlights Data on Advanced and Rare Cancers during 2022 ASCO Annual Meeting and EHA 2022 Hybrid Congress
May 5, 2022

Astellas to Present 12-Week Data from Pivotal Phase 3 SKYLIGHT 1™ Trial of Fezolinetant in Oral Session at the American College of Obstetricians and Gynecologists Annual Meeting
Apr 25, 2022

Astellas Oncology Now Accepting Applications for Annual C3 Prize to Cultivate Innovation in Cancer Care Beyond Medicine
Apr 25, 2022

University of Tokyo, Astellas Enter Second Phase of Strategic Partnership for Co-creation of Innovative New Medicines and Medical Solutions
Apr 13, 2022

European Commission Approves PADCEV™ (enfortumab vedotin) for Locally Advanced or Metastatic Urothelial Cancer
Mar 14, 2022

Astellas Announces Topline 12-week Results from Phase 3 Study of Fezolinetant for the Nonhormonal Treatment of Vasomotor Symptoms in Women in Asia
Mar 7, 2022

Astellas Announces Topline Results from Long-Term Phase 3 Safety Study of Fezolinetant which Inform Future Regulatory Filings for the Treatment of Vasomotor Symptoms Associated with Menopause
Feb 28, 2022

Astellas and Seagen Announce CHMP Confirms Positive Opinion for PADCEV™ (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer
Feb 14, 2022

Astellas and Seagen Announce Initial Results of PADCEV® (enfortumab vedotin-ejfv) in Patients With Muscle-Invasive Bladder Cancer Not Eligible for Cisplatin Chemotherapy

- Late-breaking data from Cohort H of EV-103 trial to be presented at the 2022 ASCO Genitourinary Cancers Symposium -
Feb 7, 2022

Astellas Announces Positive Safety Data from the FORTIS Study of AT845 in Adults with Late-Onset Pompe Disease

- Data presented at the 18th Annual WORLDSymposiumTM 2022 -
Dec 17, 2021

Astellas and Seagen Receive Positive CHMP Opinion for PADCEV™ (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

- If approved, PADCEV would be the first medicine for patients in the EU who have received prior platinum-based chemotherapy and a PD-1/L1 inhibitor -

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