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FDAgent — Approval Radar

Built at GPT-6 Astra Hackathon NYC · Sep 10, 2026 · New York, NY

FDAgent — Approval Radar — Demo video

Approval Radar is an Astra-powered research agent that helps biotech investors understand what could support or derail a new medicine’s FDA approval. Astra chooses research tools, queries regulatory and clinical-trial databases, reads original documents, and tests whether the evidence supports the approval case. It connects to FDAgent’s existing data tools and produces a cited brief covering clinical results, safety, manufacturing and regulatory risks. In one case, Astra found that a reassuring inspection covered research practices and did not resolve the drug’s manufacturing concern. It identified the exact evidence still needed. We completed 35 real Astra runs across 33 drug cases. Users can inspect the research trail, challenge conclusions and export findings.

Team