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View all newsSeptember 16, 2026
Lilly v. Kennedy: Whether Retatrutide Is a Drug or a Biologic Goes to the Seventh Circuit
Eli Lilly asked the FDA to classify retatrutide as a biological product; the FDA said it is a drug. A district court upheld the FDA’s reading that a protein needs more than 40 alpha amino acids, but set aside its “analogous product” reasoning and sent that question back to the agency. Lilly appealed, and the Seventh Circuit calendared oral argument for September 24, 2026. The holdings, each side’s arguments, and what the filings say the classification changes.
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