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Bladder Cancer News (Page 2)
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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 of care...
FDA Approves Adstiladrin (nadofaragene firadenovec-vncg) for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Ferring’s novel adenovirus vector-based gene therapy Adstiladrin® (nadofaragene firadenovec-vncg) is the first gene therapy approved for bladder cancer Efficacy and safety of Adstiladrin supported by...
Genentech Provides Update on Tecentriq U.S. Indication for Previously Untreated Metastatic Bladder Cancer
South San Francisco, CA – November 28th, 2022 -- Genentech, a member of the Roche Group, today announced that the company is voluntarily withdrawing the U.S. indication of Tecentriq® (atezolizumab) f...
FDA Approves Keytruda (pembrolizumab) for Patients With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer
KENILWORTH, N.J.--(BUSINESS WIRE) January 8, 2020 --Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved...
FDA Approves Padcev (enfortumab vedotin-ejfv) for Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer
TOKYO and BOTHELL, Wash., Dec. 18, 2019 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seattle Genetics, Inc. (Nasdaq:SGEN) today announced ...
FDA Approves Balversa (erdafitinib) for the Treatment of Metastatic Bladder Cancer
April 12, 2019 – The U.S. Food and Drug Administration today granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer...
AstraZeneca’s Imfinzi (durvalumab) Receives FDA Accelerated Approval for Previously Treated Patients with Advanced Bladder Cancer
May 1, 2017 – AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Imfinzi...
Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma
PRINCETON, N.J.--(BUSINESS WIRE)-- February 2, 2017 – Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Opdivo injection, for...
FDA Approves Tecentriq (atezolizumab) for Urothelial Carcinoma
May 18, 2016 – The U.S. Food and Drug Administration today approved Tecentriq (atezolizumab) to treat the most common type of bladder cancer, called urothelial carcinoma. This is the first product...