News Releases

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

Month Year

Mar 26, 2021

Astellas Garners New Indication & New Product Formulation Approvals From U.S. FDA for Children with Neurogenic Detrusor Overactivity (NDO)

Myrbetriq® (Mirabegron Extended-Release Tablets) Approved for Pediatric Patients with NDO Aged Three Years and Older Weighing 35 kg or More
Mar 26, 2021

Astellas Receives Positive CHMP Opinion for XTANDI™ (enzalutamide) for Patients with Metastatic Hormone-Sensitive Prostate Cancer

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 castration-resistant prostate cancer
Mar 26, 2021

European Medicines Agency Accepts Marketing Authorization Application for Enfortumab Vedotin

- Enfortumab vedotin to be reviewed under accelerated assessment for the treatment of locally advanced or metastatic urothelial cancer -
Mar 24, 2021

Astellas Oncology Announces Grand Prize Winner of Fifth Annual C³ Prize® Challenge

- Three innovators awarded $200,000 in total grants and resources for their work to "Change Cancer Care" beyond medicine -
- Photos 1
Mar 11, 2021

Astellas Submits New Drug Application for Enfortumab Vedotin in Japan

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
Feb 19, 2021

Astellas Announces Positive Topline Results from Two Phase 3 Pivotal Global Trials of Fezolinetant for the Nonhormonal Treatment of Vasomotor Symptoms in Postmenopausal Women
Feb 18, 2021

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

- Submissions will be Reviewed Under Real-Time Oncology Review Based on Clinical Trials EV-301 and Cohort 2 of EV-201 -
Feb 12, 2021

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 Cisplatin Chemotherapy

- Durable Tumor Responses Experienced Among Patients Previously Treated with Immunotherapy in Second Cohort of EV-201 Trial -
Feb 12, 2021

Astellas and Seagen Announce Phase 3 Trial Results Demonstrating Survival Advantage of PADCEV® (enfortumab vedotin-ejfv) in Patients with Previously Treated Advanced Urothelial Cancer

- Findings from the EV-301 Trial Showed Significant Improvements in Overall Survival and Progression-Free Survival Compared to Chemotherapy -
Feb 4, 2021

Astellas expands Top Management, names Percival Barretto-Ko as Chief Business Officer; Yoshitsugu Shitaka as Chief Scientific Officer

Oncology head Mark Reisenauer named Astellas US President; Masahide Goto named President at Astellas Institute for Regenerative Medicine

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