trove / FDA drug approvals / Columvi

Approval

FDA-approved use

Approval package

• ↗ Drugs@FDA: full approval-package overview (every PDF the FDA released)
• ↗ FDA-approved label (PDF)
• ↗ FDA Drug Trials Snapshot

Query with Claude

The fda-analyst skill answers natural-language questions about this approval by fetching the relevant FDA review PDFs at query time.

git clone https://github.com/cbetz/trove
cp -r trove/skills/fda-analyst ~/.claude/skills/

Example prompts for Columvi:

• "What was the basis for Columvi's approval — what trials, what endpoints?"
• "What adverse events did the FDA flag in the Columvi medical review?"
• "What regulatory pathway did Columvi use — priority review, breakthrough, accelerated approval?"