Astellas Pharma Inc (OP: ALPMY )
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Press releases about Astellas Pharma Inc
Actinium and Astellas Announce Research Collaboration Focused on Novel Actinium-225 Based Targeted Radiotherapies
January 13, 2021
- Builds the collaboration utilizing Actinium's Antibody Warhead Enabling (AWE) Technology Platform with selected Astellas targeting agents
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...
KaliVir Immunotherapeutics and Astellas Enter Worldwide Exclusive Licensing Agreement for Development and Commercialization of VET2-L2 Novel Oncolytic Virus
December 07, 2020
- The Collaboration will Accelerate the Research and Development of Next-generation Immuno-Oncology Therapies -
Astellas Receives Approval of EVRENZO® (roxadustat) in Japan for the Treatment of Anemia of Chronic Kidney Disease in Adult Patients Not on Dialysis
November 27, 2020
Approval by MHLW provides new HIF-PH inhibitor treatment option for healthcare providers and adult patients with anemia of CKD not on dialysis
Astellas to Present New Data on Gilteritinib in FLT3 Mutation-Positive Acute Myeloid Leukemia at the 2020 American Society of Hematology Annual Meeting
November 16, 2020
Includes five oral presentations that collectively explore the use of gilteritinib across the FLT3mut+ AML care continuum
XTANDI® (enzalutamide soft capsules) Approved by China NMPA for the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer
November 06, 2020
Enzalutamide is now NMPA-approved for both non-metastatic and metastatic castration-resistant prostate cancer
Astellas Receives U.S. FDA Fast Track Designation for ASP5354, an Investigational Near-Infrared Fluorescence Imaging Agent
October 28, 2020
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) announced today that the United States ("U.S.") Food and Drug Administration (FDA) has granted Fast Track...
U.S. FDA Grants Fast Track Designation for ASP0367/MA-0211, a Selective PPARδ Modulator being Developed for the Treatment of Primary Mitochondrial Myopathies
October 20, 2020
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the...
New Roxadustat Data in Anemia of Chronic Kidney Disease to be Released at ASN Kidney Week 2020 Reimagined
October 19, 2020
42 abstracts featuring additional insights into roxadustat and anemia of chronic kidney disease to be presented
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
October 12, 2020
- Durable Responses Observed in Patients Who Had Previously Received Immunotherapy but Were Ineligible for Cisplatin in Locally Advanced or Metastatic Setting -
Astellas and MBC BioLabs Announce Golden Ticket Competition to Help Biotech Start-ups Accelerate Early Drug Discovery and Research Efforts
September 29, 2020
Sponsorship provides a year of access to MBC BioLabs' life-science incubators and in-house Astellas expertise for scientific innovators
Astellas' Real-World Evidence Studies Provide Further Insight into Negative Impacts of Vasomotor Symptoms (VMS) Associated with Menopause
September 28, 2020
New findings to be presented at The North American Menopause Society (NAMS) 2020 Virtual Annual Meeting
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
September 18, 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
July 22, 2020
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced it has been awarded a grant from the National Institute on Drug Abuse (NIDA), part of the National...
Roxadustat Demonstrates Non-Inferiority to Darbepoetin in Phase 3 DOLOMITES Study of Anemia in Non-Dialysis-Dependent Adult Patients with Chronic Kidney Disease
June 08, 2020
- Study meets primary endpoint demonstrating non-inferiority of roxadustat to darbepoetin in correction and maintenance of hemoglobin levels
Final PROSPER Results Show XTANDI® (enzalutamide) Significantly Extends Overall Survival in Men with Non-Metastatic Castration-Resistant Prostate Cancer
May 29, 2020
Data simultaneously published in the New England Journal of Medicine and presented during the virtual scientific program of the 2020 ASCO Annual Meeting
XTANDI® (enzalutamide) Approved by Japan MHLW for the Treatment of Prostate Cancer with Distant Metastasis
May 29, 2020
XTANDI is now MHLW-approved for both metastatic hormone-sensitive prostate cancer and castration-resistant prostate cancer in Japan
FDA Approves VESIcare LS™ (solifenacin succinate) Oral Suspension for Pediatric Patients
May 27, 2020
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has approved VESIcare LS™ (solifenacin succinate)...
European Medicines Agency Accepts Astellas' Marketing Authorization Application for Roxadustat
May 20, 2020
Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China by the National Medical Products Administration
April 09, 2020
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today a new drug application (NDA) for the oral once-daily therapy XOSPATA® (gilteritinib), for the...
Astellas and Seattle Genetics Receive FDA Breakthrough Therapy Designation for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer
February 19, 2020
XTANDI® (enzalutamide) Demonstrates Significant Improvement in Overall Survival in Phase 3 PROSPER Trial of Patients with nmCRPC
February 11, 2020
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pfizer Inc. (NYSE: PFE) announced today results of the final overall survival (OS) analysis from the Phase 3...
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 Treatme
February 10, 2020
- 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 -
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
January 30, 2020
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 submission of a...
Astellas Completes Acquisition of Audentes Therapeutics
January 15, 2020
- 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...
Astellas Strengthens Immuno-oncology Pipeline with Acquisition of Xyphos Biosciences, Inc.
December 26, 2019
Acquisition adds talent and proprietary therapeutic platform to accelerate next-generation cancer immunotherapy
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 C
December 18, 2019
- First-in-Class Antibody-Drug Conjugate Directed Against Nectin-4, a Protein Highly Expressed in Urothelial Tumors1,2 -
XTANDI® (enzalutamide) Approved by U.S. FDA for the Treatment of Metastatic Castration-Sensitive Prostate Cancer
December 16, 2019
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
Astellas and MBC BioLabs Announce Golden Ticket Winners - Supporting Biotech Start-Ups to Accelerate Innovative Science
December 05, 2019
Two exciting biotechs win a year of access to life-science incubator and in-house Astellas expertise to advance their early drug discovery research