JD Supra

District Court Sets Aside FDA’s Interpretation of “Analogous” to a Protein for Purposes of the “Biological Product” Category

On September 30, 2025, the U.S. District Court for the Southern District of Indiana issued a decision vacating the decision by the Food and Drug Administration (FDA) to regulate Eli Lilly’s ...
JD Supra

Eli Lilly Files Suit Challenging the FDA’s Drug Classification of Retatrutide

On September 3, 2024, Eli Lilly filed a complaint against the FDA in the District Court for the Southern District of Indiana pursuing the latest challenge to the FDA’s application of its “biological ...
Ibj.com

Lilly seeks court ruling that could mean big money for new weight-loss drug

Eli Lilly and Co. wants a federal court to uphold a simple math equation: 41 is greater than 40. The Indianapolis-based drugmaker filed a lawsuit in federal court this month, challenging the U.S. Food ...