A digital view of the world illustrates how Astellas is a global company committed to serving patients worldwide.

News

Astellas is committed to providing timely and accurate information about our business, science and products. This section offers global resources for investors, journalists and media professionals. News and resources from our local affiliates can be viewed in the Local news section. If you are not an investor or journalist, click here.

Month Year

Dec 18, 2023

EMA Recommends Arpraziquantel for Treatment of Schistosomiasis in Preschool-Aged Children

- Astellas contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium -

TOKYO, December 18, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium (Consortium). The Consortium announced that the Committee...

Read more about EMA Recommends Arpraziquantel for Treatment of Schistosomiasis in Preschool-Aged Children
Dec 15, 2023

PADCEV^® (enfortumab vedotin-ejfv) with KEYTRUDA^® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer

– PADCEV plus pembrolizumab approved based on groundbreaking EV-302 trial –

TOKYO and NEW YORK – December 15, 2023 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that on December 15, 2023 the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv, an antibody-drug conjugate...

Read more about PADCEV^® (enfortumab vedotin-ejfv) with KEYTRUDA^® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer
Dec 11, 2023

Astellas’ VEOZA^TM (fezolinetant) Approved by European Commission for Treatment of Vasomotor Symptoms Associated with Menopause

First-in-class treatment option reduces number and intensity of hot flashes and night sweats

TOKYO, December 11, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the European Commission (EC) on December 7 approved VEOZATM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause...

Read more about Astellas’ VEOZA^TM (fezolinetant) Approved by European Commission for Treatment of Vasomotor Symptoms Associated with Menopause
Nov 30, 2023

Astellas’ Fezolinetant Reduces Frequency and Severity of VMS Associated with Menopause in Women Considered Unsuitable for Hormone Therapy

Phase 3b DAYLIGHT study being presented at ESG 2023 demonstrated fezolinetant 45 mg achieved statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms due to menopause and patient-reported sleep disturbance at 24 weeks

TOKYO, November 30, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) will present 24-week results from the Phase 3b DAYLIGHT clinical trial examining the efficacy and safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of...

Read more about Astellas’ Fezolinetant Reduces Frequency and Severity of VMS Associated with Menopause in Women Considered Unsuitable for Hormone Therapy
Nov 30, 2023

FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV^® (enfortumab vedotin-ejfv) with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

– Results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and progression-free survival vs standard platinum containing chemotherapy–

TOKYO and BOTHELL, Wash.– November 30, 2023 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) and Seagen Inc. (Nasdaq: SGEN) today announced that on November 30, 2023 the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as a combination therapy for the treatment...

Read more about FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV^® (enfortumab vedotin-ejfv) with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

Show per page

Discover more

Media contacts

Return to media homepage

Subscribe to news alerts

Choose Language

News