EMA validates PolyPid D-PLEX100 marketing authorization application, triggers formal review

PYPD•2026-10-01

The EMA validated PolyPid’s marketing authorization application for D-PLEX100 to prevent incisional infections after abdominal surgery, triggering a formal review; the U.S. NDA remains under FDA Priority Review with a Nov. 28, 2026, goal date.

EMA validates PolyPid D-PLEX100 marketing authorization application, triggers formal review

1. Regulatory review begins

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