PolyPid Submits NDA to FDA for D-PLEX₁₀₀, Antibiotic Product for Surgical Site Infections

PolyPid announced the completion of its New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for D-PLEX₁₀₀. The submission marks a significant step for the company as it seeks approval for its novel product.

The company’s NDA package includes comprehensive data from preclinical studies, manufacturing information, and clinical trials. D-PLEX₁₀₀ is designed to provide a prolonged release of antibiotics directly at the surgical site. The goal of this approach is to reduce the risk of infections following surgery.

Newsflash | Powered by GeneOnline AI

Source: GO-AI-ne1

For any suggestion and feedback, please contact us.

Date: June 1, 2026

Author

GOAI