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FDA Approves First Gene Therapy for Non-Muscle-Invasive Bladder Cancer

The FDA has approved nadofaragene firadenovec (Adstiladrin) as the first gene therapy for the treatment of high-risk bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC), the agency announced on Friday. An adenoviral vector-based product, nadofaragene firadenovec, is specifically indicated for adult patients with carcinoma in situ (CIS) with or without papillary tumors. Approval was based on […]

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