The FDA on September 9, 2025, approved INLEXZO® for adults with Bacillus Calmette-Guérin (BCG)-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma in Situ (CIS) with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder. INLEXZO® is a product of Janssen Biotech, Inc.
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