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Extended Lymphadenectomy Does Not Lead to Survival Benefit in MIBC

Extended lymphadenectomy at the time of radical cystectomy did not produce a significant improvement in disease-free survival (DFS) or overall survival (OS) vs standard lymphadenectomy for patients with muscle-invasive bladder cancer.

FDA Issues Complete Response Letter to BLA for N-803 in BCG-unresponsive NMIBC in Situ

The FDA has issued a complete response letter regarding the biologics license application for N-803 in combination with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without Ta or T1 disease.

FDA Grants 501K Clearance to Bladder EpiCheck for Surveillance in NMIBC

The FDA has granted 510K clearance to Bladder EpiCheck for use as a noninvasive method for surveillance of tumor recurrence in previously diagnosed patients with non–muscle invasive bladder cancer, in conjunction with cystoscopy.

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