Posted by Michael Wonder on 02 Jun 2026
PolyPid completes new drug application submission to FDA for D-PLEX₁₀₀
1 June 2026 - PolyPid today announced the successful completion of its new drug application submission on a rolling review basis to the US FDA for D-PLEX100, the Company’s lead product candidate for the prevention of surgical site infections in patients undergoing colorectal surgery.
The Company anticipates a potential FDA decision in the first quarter of 2027 under the PDUFA review timeline.
