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Astellas Pharma Inc (OP: ALPMY )

16.21 USD -0.35 (-2.11%)
Official Closing Price Updated: 3:57 PM EST, Jan 22, 2021 Add to My Watchlist
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Press releases about Astellas Pharma Inc

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Actinium and Astellas Announce Research Collaboration Focused on Novel Actinium-225 Based Targeted Radiotherapies
- Builds the collaboration utilizing Actinium's Antibody Warhead Enabling (AWE) Technology Platform with selected Astellas targeting agents 
From PR Newswire
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
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... 
From PR Newswire
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
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... 
From PR Newswire
KaliVir Immunotherapeutics and Astellas Enter Worldwide Exclusive Licensing Agreement for Development and Commercialization of VET2-L2 Novel Oncolytic Virus
- The Collaboration will Accelerate the Research and Development of Next-generation Immuno-Oncology Therapies - 
From PR Newswire
Astellas Receives Approval of EVRENZO® (roxadustat) in Japan for the Treatment of Anemia of Chronic Kidney Disease in Adult Patients Not on Dialysis
Approval by MHLW provides new HIF-PH inhibitor treatment option for healthcare providers and adult patients with anemia of CKD not on dialysis 
From PR Newswire
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 
From PR Newswire
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 
From PR Newswire
Astellas Receives U.S. FDA Fast Track Designation for ASP5354, an Investigational Near-Infrared Fluorescence Imaging Agent
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... 
From PR Newswire
U.S. FDA Grants Fast Track Designation for ASP0367/MA-0211, a Selective PPARδ Modulator being Developed for the Treatment of Primary Mitochondrial Myopathies
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... 
From PR Newswire
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 
From PR Newswire
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 - 
From PR Newswire
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 
From PR Newswire
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 
From PR Newswire
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 - 
From PR Newswire
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
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... 
From PR Newswire
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 
From PR Newswire
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 
From PR Newswire
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 
From PR Newswire
FDA Approves VESIcare LS™ (solifenacin succinate) Oral Suspension for Pediatric Patients
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)... 
From PR Newswire
European Medicines Agency Accepts Astellas' Marketing Authorization Application for Roxadustat
Submission for the treatment of anemia in adult patients with chronic kidney disease 
From PR Newswire
Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China by the National Medical Products Administration
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... 
From PR Newswire
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 - 
From PR Newswire
XTANDI® (enzalutamide) Demonstrates Significant Improvement in Overall Survival in Phase 3 PROSPER Trial of Patients with nmCRPC
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... 
From PR Newswire
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
- 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 - 
From PR Newswire
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
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... 
From PR Newswire
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... 
From PR Newswire
Astellas Strengthens Immuno-oncology Pipeline with Acquisition of Xyphos Biosciences, Inc.
Acquisition adds talent and proprietary therapeutic platform to accelerate next-generation cancer immunotherapy 
From PR Newswire
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
- First-in-Class Antibody-Drug Conjugate Directed Against Nectin-4, a Protein Highly Expressed in Urothelial Tumors1,2 - 
From PR Newswire
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 
From PR Newswire
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 
From PR Newswire
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