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MediWound (MDWD) FDA Events

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FDA Events for MediWound (MDWD)

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

MediWound's Drugs in FDA Review

EscharEx - FDA Regulatory Timeline and Events

EscharEx is a drug developed by MediWound 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.

NexoBrid - FDA Regulatory Timeline and Events

NexoBrid is a drug developed by MediWound for the following indication: Enzymatically removes nonviable burn tissue. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

MediWound FDA Events - Frequently Asked Questions

Yes, MediWound (MDWD) has received FDA approval for NexoBrid. This page tracks recent and historical FDA regulatory events related to MediWound's drug portfolio.

In the past two years, MediWound (MDWD) has reported FDA regulatory activity for the following drugs: EscharEx and NexoBrid.

The most recent FDA-related event for MediWound occurred on May 13, 2025, involving EscharEx. The update was categorized as "Publication," with the company reporting: "MediWound Ltd. announced the publication of a peer-reviewed post hoc analysis in Wounds."

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

  • Chronic Wounds - EscharEx
  • Enzymatically removes nonviable burn tissue - NexoBrid

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