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MiMedx Group (MDXG) FDA Events

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FDA Events for MiMedx Group (MDXG)

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

EPIFIX - FDA Regulatory Timeline and Events

EPIFIX is a drug developed by MiMedx Group for the following indication: Chronic wounds. 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.

MiMedx Group FDA Events - Frequently Asked Questions

As of now, MiMedx Group (MDXG) has not received any FDA approvals for its therapy in the last two years.

In the past two years, MiMedx Group (MDXG) has reported FDA regulatory activity for EPIFIX.

The most recent FDA-related event for MiMedx Group occurred on May 5, 2025, involving EPIFIX. The update was categorized as "Publication," with the company reporting: "MiMedx Group, Inc. announced the publication of its health economics data for reconstruction of cutaneous wounds with EPIFIX® (Dehydrated Human Amnion Chorion Membrane, or DHACM) following Mohs surgery."

Currently, MiMedx Group has one therapy (EPIFIX) targeting the following condition: Chronic wounds.

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:MDXG) was last updated on 7/10/2025 by MarketBeat.com Staff
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