PolyPid's D-PLEX100 Receives FDA Approval for NDA Submission, Rolling Review Process
ByAinvest
Wednesday, Dec 3, 2025 8:32 am ET1min read
PYPD--
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.
Stay ahead of the market.
Get curated U.S. market news, insights and key dates delivered to your inbox.
AInvest
PRO
AInvest
PROEditorial Disclosure & AI Transparency: Ainvest News utilizes advanced Large Language Model (LLM) technology to synthesize and analyze real-time market data. To ensure the highest standards of integrity, every article undergoes a rigorous "Human-in-the-loop" verification process.
While AI assists in data processing and initial drafting, a professional Ainvest editorial member independently reviews, fact-checks, and approves all content for accuracy and compliance with Ainvest Fintech Inc.’s editorial standards. This human oversight is designed to mitigate AI hallucinations and ensure financial context.
Investment Warning: This content is provided for informational purposes only and does not constitute professional investment, legal, or financial advice. Markets involve inherent risks. Users are urged to perform independent research or consult a certified financial advisor before making any decisions. Ainvest Fintech Inc. disclaims all liability for actions taken based on this information. Found an error?Report an Issue
Comments
No comments yet