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Vericel (VCEL) FDA Events

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FDA Events for Vericel (VCEL)

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

NexoBrid - FDA Regulatory Timeline and Events

NexoBrid is a drug developed by Vericel 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.

Vericel FDA Events - Frequently Asked Questions

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

In the past two years, Vericel (VCEL) has reported FDA regulatory activity for NexoBrid.

The most recent FDA-related event for Vericel occurred on February 25, 2025, involving NexoBrid. The update was categorized as "Publication," with the company reporting: "MediWound Ltd. announced the publication of its Phase III Children Innovative Debridement Study (CIDS) in Burns, the peer-reviewed Journal of the International Society for Burn Injuries (ISBI)."

Currently, Vericel has one therapy (NexoBrid) targeting the following condition: Enzymatically removes nonviable burn tissue.

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:VCEL) was last updated on 7/9/2025 by MarketBeat.com Staff
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