Drugs / Amniotic Suspension Allograft
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | ReNu | osteoarthritis, knee | 2026-07-06 | “accepted for review the Company's Biologics License Application (BLA) for ReNu®, a cryopreserved amniotic suspension allograft” organogenesis.com ↗ |
| Filed | US (FDA) | ReNu | osteoarthritis, knee | 2026-04-28 | “completion of a rolling Biologics License Application (BLA) submission to the Food and Drug Administration (FDA) for ReNu®” organogenesis.com ↗ |
| Filed | US (FDA) | ReNu | osteoarthritis, knee | 2025-12-23 | “today announced the initiation of a rolling submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for ReNu,®” organogenesis.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT06000410 | Sep 2023 → Aug 2025 | osteoarthritis, knee | Organogenesis | Completed | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Amniotic Suspension Allograft | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06000410 ↗ |
| Known as | ASA | “A Phase 3 Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of Amniotic Suspension Allograft (ASA) in Patients With...” NCT06000410 ↗ |
| Modality | Other / unclassified | “This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.” NCT06000410 ↗ |