ALPMY News and Press, Astellas Pharma Inc. ADR From 03/29/21

Astellas' XOSPATA® (gilteritinib) Meets Overall Survival Endpoint in COMMODORE Trial of Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation - Confirmatory Phase 3 trial in China, other countries stopped early due to positive results at planned i...

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

The Committee for Medicinal Products for Human Use ((CHMP)) of the European Medicines Agency ((EMA)) has adopted a positive opinion on an additional indication for Astellas Pharma (ALPMY) and Pfizer's (PFE) XTANDI treatment for adult men with metastatic hormone-sensitive p...

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 ...

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 - PR Newswire TOKYO and BOTHELL, ...

The pharmaceutical industry has a reputation for resilience. Many pharma players that garnered noteworthy momentum amid the COVID-19 pandemic are holding strong even as the pandemic is on a decline. That’s because these companies are now focusing on other rare and/or chronic diseases. ...

Astellas Announces Positive Topline Results from Two Phase 3 Pivotal Global Trials of Fezolinetant for the Nonhormonal Treatment of Vasomotor Symptoms in Postmenopausal Women PR Newswire TOKYO , Feb. 19, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503) ...

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 Clini...

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 Previ...

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 P...