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PolyPid's D-PLEX100 Receives FDA Approval for NDA Submission, Rolling Review Process
ByAinvest
Wednesday, Dec 3, 2025 8:32 am ET1min read
PolyPid announced positive FDA pre-NDA meeting minutes for D-PLEX100, supporting its NDA submission for preventing surgical site infections in abdominal colorectal surgeries. The FDA agreed that the existing clinical data package is adequate to support review, and the company can submit the first completed sections in early 2026. The meeting feedback validates PolyPid's regulatory strategy and keeps it on track to bring this potentially transformative treatment to patients.
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