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Following Positive Communication with the FDA, Regulatory Pathway Clarified for D-PLEX100 for Prevention of Abdominal Colorectal Surgical Site Infections Company Expects to Resume Patient...
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PETACH TIKVA, Israel, Jan. 31, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today...
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• Regulatory Pathway for a Potential NDA Submission Clarified Following Recent Interactions with the FDA • FDA Acknowledged that SHIELD I Pre-specified Subgroup Results May Provide Supportive...
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D-PLEX100 Achieved in Phase 2 Trial Significant Reduction in SSIs in Patients with Multiple Preoperative Risk Factors Versus Standard of Care Results Consistent with SHIELD I Phase 3 Post-hoc...
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Meeting Scheduled for January 2023 PolyPid Recently Provided FDA with Currently Available Data from Completed SHIELD I Phase 3 Study in Advance of Meeting PETACH TIKVA, Israel, Dec. 12,...
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PETACH TIKVA, Israel, Dec. 09, 2022 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today...
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PETACH TIKVA, Israel, Nov. 29, 2022 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today...
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Company Intends to Meet with U.S. and EU Regulatory Authorities to Discuss Data from SHIELD I Phase 3 Study and Regulatory Pathway for D-PLEX100 in First Quarter of 2023 Implemented a Cost Reduction...
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PETACH TIKVA, Israel, Oct. 26, 2022 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced...
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Reduction of Approximately 20% in Organization Headcount Company Expects to Extend Cash Runway into Q3 2023 PolyPid Intends to Discuss Regulatory Pathway for D-PLEX100 for Prevention of Surgical...