FDA Grants Orphan Drug Designation to FS2 for Potential Treatment of Idiopathic Pulmonary Fibrosis

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to FS2, also known as kynurenic acid, for its potential use in treating idiopathic pulmonary fibrosis (IPF). This designation applies to the investigational treatment being developed by BirchBioMed, a biotechnology company focused on addressing unmet medical needs.

Orphan drug designation is a status provided by the FDA to encourage the development of treatments for rare diseases or conditions affecting fewer than 200,000 people in the United States. Idiopathic pulmonary fibrosis is a chronic and progressive lung disease characterized by scarring of lung tissue, which leads to severe breathing difficulties. The FDA’s decision highlights FS2’s potential as a therapeutic option for this condition. Further clinical studies will determine its safety and efficacy in treating IPF.

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Date: December 2, 2025

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