October 28, 2025 at 03:54PM YESCARTA

For the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Axicabtagene ciloleucel is not indicated for the treatment of patients with primary central nervous system lymphoma.

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October 24, 2025 at 05:01PM Expanded Access (Compassionate Use) Submission Data

Expanded Access (Compassionate Use) Submission Data

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October 24, 2025 at 05:00PM Vaccines and Related Biological Products Advisory Committee January 26, 2023 Meeting Announcement - 01/26/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) January 26, 2023 Meeting Announcement and meeting materials.

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October 24, 2025 at 04:18PM Infectious Disease Tests

Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

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October 24, 2025 at 03:50PM Elecsys Chagas

Elecsys Chagas is an in vitro immunoassay for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi, the causative agent of the Chagas disease) in human serum and plasma. Elecsys Chagas is intended to screen individual human donors, including volunteer donors of whole blood.

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October 22, 2025 at 09:47PM Administrative Guidances

This page lists Administrative Guidance documents.

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October 22, 2025 at 09:37PM FDA Rare Disease Innovation Hub

FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.

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October 21, 2025 at 03:11PM Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

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