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Organogenesis (ORGO) FDA Events

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FDA Events for Organogenesis (ORGO)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Organogenesis (ORGO). Over the past two years, Organogenesis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as NuShield and ReNu. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Organogenesis' Drugs in FDA Review

NuShield - FDA Regulatory Timeline and Events

NuShield is a drug developed by Organogenesis for the following indication: For Diabetic Foot Ulcers. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ReNu - FDA Regulatory Timeline and Events

ReNu is a drug developed by Organogenesis for the following indication: for Knee Osteoarthritis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Organogenesis FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Organogenesis (ORGO) has reported FDA regulatory activity for the following drugs: NuShield and ReNu.

The most recent FDA-related event for Organogenesis occurred on October 1, 2024, involving NuShield. The update was categorized as "Publication," with the company reporting: "Organogenesis Holdings Inc. announced the publication of "Dehydrated Amnion Chorion Membrane Versus Standard of Care for Diabetic Foot Ulcers: A Randomised Controlled Trial" in the Journal of Wound Care."

Current therapies from Organogenesis in review with the FDA target conditions such as:

  • For Diabetic Foot Ulcers - NuShield
  • for Knee Osteoarthritis - ReNu

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:ORGO) was last updated on 7/10/2025 by MarketBeat.com Staff
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