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The Professional Network for Healthcare Experts
FDA accepts UroGen’s UGN-103 NDA for recurrent low-grade intermediate-risk bladder cancer
The submission seeks approval for a next-generation mitomycin formulation designed for intravesical treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, building on the same drug-delivery platform as FDA-approved Zusduri.
nuaxia
Aug 182 min read
FDA Approves MSD’s Keytruda Combinations with Padcev for Muscle-Invasive Bladder Cancer
The approvals expand the use of Keytruda and Keytruda Qlex alongside Padcev into the perioperative treatment setting for adults with muscle-invasive bladder cancer.
nuaxia
Jul 134 min read
FDA Approves AstraZeneca’s Imfinzi Plus BCG for High-Risk Bladder Cancer
The approval introduces the first immunotherapy combination for BCG-naïve high-risk non-muscle-invasive bladder cancer, marking a potential shift in the standard of care.
nuaxia
Jun 22 min read
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