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BioWorld - Monday, May 12, 2025
Home » Keywords » N-803

Items Tagged with 'N-803'

ARTICLES

Anktiva

Immunitybio’s bladder cancer therapy, Anktiva, gets FDA approval

April 23, 2024
By Lee Landenberger
After several delays, the interleukin-15 superagonist Anktiva (nogapendekin alfa inbakicept) from Immunitybio Inc. has been approved by the U.S. FDA for treating bladder cancer, specifically Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
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Immunitybio’s bladder cancer candidate hit with a CRL

May 11, 2023
By Lee Landenberger
The U.S. FDA issued a complete response letter regarding the BLA for Immunitybio Inc.’s bladder cancer treatment, N-803 (Anktiva), halting the drug’s development and slicing the stock value in half. The problems stem from the FDA’s pre-license inspection of Immunitybio’s third-party contract manufacturing organizations, the company said. It said the FDA also had recommendations for specific chemistry, manufacturing and controls issues and assays that needed to be resolved before the BLA can be approved.
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Soon-Shiong’s Nantkwest, Immunitybio still chasing cancer breakthroughs

Jan. 23, 2020
By Michael Fitzhugh
Physician, scientist and investor Patrick Soon-Shiong might be considered a "square peg in a round hole," he admits. But the Abraxane inventor's work to enlist natural killer, dendritic and T cells in what he calls a "triangle offense" against cancer is finally coalescing, he recently told BioWorld.
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