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Month Year

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
Nov 16, 2023

University of Tsukuba and Astellas Confirm a Strategic Partnership

- Accelerating the development of the life science ecosystem centered on Tsukuba -

TOKYO and IBARAKI, November 16, 2023 - University of Tsukuba (President: Kyosuke Nagata) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that they have signed a letter of confirmation regarding a strategic partnership to accelerate the digitalization of the drug...

Read more about University of Tsukuba and Astellas Confirm a Strategic Partnership
Nov 16, 2023

Pfizer and Astellas' XTANDI^® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting

XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy* in nonmetastatic castration-sensitive prostate cancer

TOKYO and NEW YORK, November 16, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for XTANDI®...

Read more about Pfizer and Astellas' XTANDI^® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting

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