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.
- Drug:
- NexoBrid
- Announced Date:
- February 25, 2025
- Indication:
- Enzymatically removes nonviable burn tissue
Announcement
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).
AI Summary
MediWound Ltd. recently announced that its Phase III Children Innovative Debridement Study (CIDS) has been published in Burns, the peer‐reviewed journal of the International Society for Burn Injuries (ISBI). This study, conducted in multiple centers across the US, EU, Israel, and India, focused on evaluating the safety and effectiveness of NexoBrid® compared to standard care in pediatric patients with deep partial- and full-thickness thermal burns. The results demonstrated that NexoBrid provided faster removal of eschar, reduced the need for surgical intervention, and preserved healthy tissue, offering a rapid non-surgical alternative for young burn victims. These findings supported the recent label expansion for pediatric use in key regions including the U.S., E.U., and Japan and further underline NexoBrid’s clinical benefits and potential to transform burn care for children.
Read Announcement- Drug:
- NexoBrid
- Announced Date:
- August 15, 2024
- Indication:
- Enzymatically removes nonviable burn tissue
Announcement
MediWound Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for NexoBrid® (anacaulase-bcdb) allowing for eschar removal in pediatric patients aged newborn through eighteen with deep partial- and/or full-thickness thermal burns.
AI Summary
MediWound Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for pediatric use. This new indication allows pediatric patients from newborn through eighteen years old with deep partial- and full-thickness thermal burns to receive NexoBrid for eschar removal. The treatment helps remove the dead burn tissue without damaging healthy tissue, offering a less invasive and more effective alternative to traditional surgical methods.
This approval is based on the strong safety and efficacy data gathered from a global Phase III clinical trial, which focused on hospitalized pediatric patients. With pediatric burn victims making up a significant portion of the burn patient population, this milestone is expected to reduce trauma for both the children and their families. MediWound’s commitment to advancing burn care is highlighted by this significant step in expanding treatment options for young burn victims in the U.S.
Read Announcement- Drug:
- NexoBrid
- Announced Date:
- August 5, 2024
- Indication:
- Enzymatically removes nonviable burn tissue
Announcement
MediWound Ltd. announced the positive results of the NEXT—an Expanded Access Protocol. NEXT, initiated in 2019, aimed to ensure the continuous availability of NexoBrid® in burn centers until its commercialization.
AI Summary
MediWound Ltd. announced positive results from the NEXT Expanded Access Protocol, which was initiated in 2019 to ensure that burn centers had continuous access to NexoBrid® until its full commercialization. The NEXT program played a key role in keeping the treatment available, allowing physicians to maintain their expertise and providing burn victims with ongoing access to this life-saving therapy. By using NexoBrid®, clinicians were able to quickly remove burned tissue, reduce the need for surgical interventions, and improve patient recovery outcomes. In addition, the protocol facilitated the collection of valuable real-world safety and clinical data that supported previous trial findings. These encouraging results show that maintaining access to innovative treatments like NexoBrid® is essential for advancing burn care and improving the overall standard of treatment for severe burn injuries.
Read Announcement
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
FDA Event Stage Terminology & Abbreviation Guide
- 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
Free VCEL Stock Alerts