FDA recognizes need for immunogenicity assays in therapeutics with carriers or conjugates

A new article in the journal Nucleic Acid Therapeutics addresses the recognition by the U.S. Food and Drug Administration that immunogenicity assays may be necessary to measure immune responses to different components of oligonucleotide therapeutic (ONT) drugs, especially when the therapeutic includes carriers or conjugates.

Mar 3, 2025 - 16:44
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A new article in the journal Nucleic Acid Therapeutics addresses the recognition by the U.S. Food and Drug Administration that immunogenicity assays may be necessary to measure immune responses to different components of oligonucleotide therapeutic (ONT) drugs, especially when the therapeutic includes carriers or conjugates.