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Month Year

Sep 30, 2022

European Medicines Agency Accepts Astellas’ Marketing Authorization Application for Fezolinetant

If authorized by the European Commission, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause

TOKYO, September 30, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the European Medicines Agency (EMA) has accepted for regulatory review the company’s marketing authorization application...

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Sep 26, 2022

Astellas Confirms District Court Decision for an Interim Injunction Against Hospira for LEXISCAN® 0.4mg/mL

TOKYO, September 26, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) confirms the U.S. District Court for the District of Delaware’s order granting an interim injunction enjoining Hospira from launching its generic version of...

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Sep 12, 2022

Astellas, Seagen and Merck Announce Results of Clinical Trial Investigating PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) and PADCEV as Monotherapy in First-Line Advanced Urothelial Cancer

– Results demonstrated a 64.5% confirmed objective response rate in patients treated with investigational combination of enfortumab vedotin and pembrolizumab –

TOKYO, BOTHELL, Wash. and RAHWAY, N.J. -- September 12, 2022 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”), Seagen Inc. (Nasdaq:SGEN) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today...

Read more about Astellas, Seagen and Merck Announce Results of Clinical Trial Investigating PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) and PADCEV as Monotherapy in First-Line Advanced Urothelial Cancer
Sep 5, 2022

Astellas Announces Topline Results from Phase 3 Long-Term Safety Study of Fezolinetant in Mainland China

Clinical trial evaluated the safety and tolerability of 30 mg dose for the treatment of vasomotor symptoms (VMS) associated with menopause

TOKYO, September 5, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced topline results from the Phase 3 MOONLIGHT 3™ clinical trial in women in mainland China evaluating the long-term safety...

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Aug 18, 2022

U.S. FDA Accepts Astellas’ New Drug Application for Fezolinetant

If approved by the FDA, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause

TOKYO, August 18, 2022 – 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 accepted the company’s New Drug Application (NDA) for fezolinetant, an investigational oral...

Read more about U.S. FDA Accepts Astellas’ New Drug Application for Fezolinetant

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