News releases from Astellas Pharma Inc.
News releases from Astellas Pharma Inc.
Japan's MHLW Approves PADCEV® (enfortumab vedotin) for Advanced Urothelial Cancer
September 27, 2021
- Enfortumab vedotin is the first and only antibody-drug conjugate (ADC) approved in Japan for patients with advanced urothelial cancer -
Astellas to Present Fezolinetant 12-Week Findings from Phase 3 SKYLIGHT 2™ Trial in Oral Session at The North American Menopause Society 2021 Annual Meeting
September 22, 2021
Astellas' investigational non-hormonal treatment demonstrates reduction in frequency and severity of moderate to severe vasomotor symptoms (VMS) associated with menopause
Astellas and MBC BioLabs Announce Future Innovator Prize to Help Biotech Start-ups Accelerate Early Drug Discovery and Research Efforts
September 21, 2021
Sponsorship provides a year of access to MBC BioLabs' life-science incubators and in-house Astellas expertise for scientific innovators
Astellas Reports Update to September 1 Announcement on the ASPIRO Clinical Trial of AT132 in Patients with X-linked Myotubular Myopathy
September 14, 2021
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reports that the ASPIRO clinical trial participant, who developed a serious adverse event as described on...
Astellas Provides Update on ASPIRO Clinical Trial of AT132 in Patients with X-linked Myotubular Myopathy
September 01, 2021
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced that it has voluntarily paused screening and dosing of additional participants in its ASPIRO clinical...
Astellas Receives European Commission Approval for First-in-Class EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease
August 19, 2021
Roxadustat is the first orally administered hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) inhibitor available for adult patients with anemia associated with chronic kidney disease in Europe
Astellas Partners with LabCentral to Help Emerging Biotechs Accelerate Preclinical Scientific Research
August 18, 2021
Astellas' "Future Innovator Prize" sponsorship provides access to life-science incubator and in-house Astellas expertise for scientific entrepreneurs with cutting-edge ideas
U.S. Food and Drug Administration Expands Indication for PROGRAF® for Prevention of Organ Rejection in Adult and Pediatric Lung Transplant Recipients
July 20, 2021
- PROGRAF Becomes First Immunosuppressive Drug Approved in the U.S. for People Receiving a Lung Transplant -
U.S. FDA Grants Regular Approval and Expands Indication for PADCEV® (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer
July 09, 2021
Astellas Receives Positive CHMP Opinion for EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease
June 25, 2021
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and FibroGen, Inc. (Nasdaq: FGEN, CEO: Enrique Conterno, "FibroGen") today announced the Committee for Medicinal...
New Research Reflects Astellas' Commitment to Acute Myeloid Leukemia at EHA 2021 Virtual Congress
June 08, 2021
Eight abstracts cover FLT3 mutation-positive AML, patient treatment preferences and utilization in hard-to-treat blood cancer
Astellas and Seagen Announce Updated Results from Two Trials of PADCEV® (enfortumab vedotin-ejfv) in Patients with Locally Advanced or Metastatic Urothelial Cancer Not Eligible for Cisplatin Chemother
May 19, 2021
- Durable Responses Observed in Second Cohort of Patients in Pivotal EV-201 Trial of PADCEV and in Initial First-Line Cohort of the EV-103 Trial Evaluating PADCEV in Combination with KEYTRUDA®...
Astellas to Present Data from Expanding Oncology Portfolio During the 2021 ASCO Annual Meeting
May 17, 2021
Astellas' ambitious innovation and committed collaboration support new research on investigational and approved therapies in hard-to-treat cancers
Japan's Ministry of Health, Labour and Welfare Grants Priority Review for Enfortumab Vedotin New Drug Application
May 13, 2021
NDA, submitted in March, is for locally advanced or metastatic urothelial cancer that has progressed after anti-cancer medication
Astellas' XTANDI™ (enzalutamide) Approved by European Commission for Men with Metastatic Hormone-Sensitive Prostate Cancer
May 04, 2021
Enzalutamide is now the only oral therapy approved by the European Commission to treat three distinct types of advanced prostate cancer
Astellas and Seagen Announce U.S. FDA Acceptance of Two Supplemental Biologics License Applications for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer
April 19, 2021
Astellas' XOSPATA® (gilteritinib) Meets Overall Survival Endpoint in COMMODORE Trial of Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation
March 29, 2021
- Confirmatory Phase 3 trial in China, other countries stopped early due to positive results at planned interim analysis -
Astellas Garners New Indication & New Product Formulation Approvals From U.S. FDA for Children with Neurogenic Detrusor Overactivity (NDO)
March 26, 2021
Myrbetriq® (Mirabegron Extended-Release Tablets) Approved for Pediatric Patients with NDO Aged Three Years and Older Weighing 35 kg or More
Astellas Receives Positive CHMP Opinion for XTANDI™ (enzalutamide) for Patients with Metastatic Hormone-Sensitive Prostate Cancer
March 26, 2021
If approved by the European Commission, enzalutamide will be the only oral therapy for the treatment of metastatic hormone-sensitive prostate cancer in addition to non-metastatic and metastatic...
European Medicines Agency Accepts Marketing Authorization Application for Enfortumab Vedotin
March 26, 2021
- Enfortumab vedotin to be reviewed under accelerated assessment for the treatment of locally advanced or metastatic urothelial cancer -
Enfortumab vedotin to be reviewed by Ministry of Health, Labour and Welfare for patients with locally advanced or metastatic urothelial cancer that has progressed after anti-cancer medication
Astellas Announces Positive Topline Results from Two Phase 3 Pivotal Global Trials of Fezolinetant for the Nonhormonal Treatment of Vasomotor Symptoms in Postmenopausal Women
February 19, 2021
Astellas Pharma Inc. (TSE: 4503) (President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced positive topline results from the Phase 3 pivotal SKYLIGHT 1™ and SKYLIGHT 2™ clinical trials for...
Astellas and Seagen Announce Submission of Two Supplemental Biologics License Applications to the U.S. FDA for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer
February 18, 2021
- Submissions will be Reviewed Under Real-Time Oncology Review Based on Clinical Trials EV-301 and Cohort 2 of EV-201 -
Astellas and Seagen Announce Phase 3 Trial Results Demonstrating Survival Advantage of PADCEV® (enfortumab vedotin-ejfv) in Patients with Previously Treated Advanced Urothelial Cancer
February 12, 2021
- Findings from the EV-301 Trial Showed Significant Improvements in Overall Survival and Progression-Free Survival Compared to Chemotherapy -
Astellas and Seagen Announce Presentation of Results from PADCEV® (enfortumab vedotin-ejfv) Pivotal Trial in Patients with Previously Treated Advanced Urothelial Cancer Who Were Ineligible for Cisplat
February 12, 2021
- Durable Tumor Responses Experienced Among Patients Previously Treated with Immunotherapy in Second Cohort of EV-201 Trial -
Astellas' XOSPATA® (gilteritinib) Receives Conditional Approval by China's National Medical Products Administration for Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation
February 03, 2021
- Accelerated approval follows priority review designation and inclusion in overseas new drugs urgently needed in clinical settings
Astellas Achieves 100% Score on Corporate Equality Index for Seventh Consecutive Year
January 28, 2021
For the seventh consecutive year, Astellas has achieved a perfect score on the Human Rights Campaign Foundation's (HRC) annual Corporate Equality Index (the Index).
FDA Accepts for Priority Review the New Drug Application for mirabegron for Oral Suspension and Supplemental New Drug Application for Myrbetriq® (mirabegron) Tablets in Pediatric Patients
January 06, 2021
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that the U.S. Food and Drug Administration (FDA) accepted priority review for its New Drug...
Astellas Reports XOSPATA® (gilteritinib) in Combination with Azacitidine Did Not Meet Endpoint of Overall Survival in Newly Diagnosed FLT3 Mutation-Positive Acute Myeloid Leukemia Patients Ineligible
December 21, 2020
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that a Phase 3 trial of XOSPATA® (gilteritinib) plus azacitidine versus azacitidine alone in newly...