Let’s dive into Sarepta’s recent feud with FDA by building a RAG application on publicly accessible FDA documents, SEC filings, Press Reports, Publications, and Abstracts 🧵

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One way to augment preclinical tox models is to prioritize targets with lower risk, using historical data from in-human clinical trials, e.g. the Drug Induced Liver Injury Rank (DILIrank) Dataset published by FDA

This guidance comes on the heels of increasing recognition that failure of pre-clinical models translating into the clinic is one of the biggest reasons for high costs of drug development, especially in case of first-in-class targets

FDA’s recent guidance on de-prioritizing animal testing places heavy emphasis on developing better computational models for estimating drug toxicity, immunogenicity, and pharmacodynamics in humans