Jan, 2024

U.S.A.
News / Therapeutic Area News
European Medicines Agency Validates Type II Variation Application for PADCEV™ (enfortumab vedotin) with KEYTRUDA®(pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
– Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival – – If approved, PADCEV with KEYTRUDA would be the...
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U.S.A.
News / Therapeutic Area News
Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the U.S. Food and Drug Administration (FDA) issued a complete response letter on January 4, 2024,...
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Dec, 2023

U.S.A.
News / Therapeutic Area News
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 – – Confirmatory trial found PADCEV plus pembrolizumab nearly doubled median overall survival compared to standard...
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U.S.A.
News / Therapeutic Area News
Astellas' VEOZA™ (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, Dec. 10, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura,...
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U.S.A.
News / Therapeutic Area News
FDA Approves Expanded Use of CRESEMBA® (isavuconazonium sulfate) in Children with Invasive Aspergillosis and Invasive Mucormycosis
CRESEMBA is the only azole antifungal therapy approved for pediatric patients as young as one affected by these serious, potentially life-threatening infections Approval based on results of two...
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