FibroBiologics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by FibroBiologics (FBLG).
Over the past two years, FibroBiologics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Human. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Human dermal fibroblast FDA Regulatory Events
Human dermal fibroblast is a drug developed by FibroBiologics for the following indication: in Chronic-Relapse Psoriasis Treatment.
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.
- Drug:
- Human dermal fibroblast
- Announced Date:
- September 11, 2025
- Indication:
- in Chronic-Relapse Psoriasis Treatment
Announcement
FibroBiologics, Inc. announced positive IND-enabling updates from its psoriasis research program demonstrating the potential of human dermal fibroblast (HDF) spheroids as a novel therapeutic approach for chronic-relapse psoriasis.
AI Summary
FibroBiologics, Inc. announced positive IND-enabling updates from its psoriasis research program showing human dermal fibroblast (HDF) spheroids could treat chronic-relapse psoriasis. In an acute psoriasis model, a single HDF spheroid dose matched the effect of multiple injections of an anti–IL-23 antibody. In a chronic-relapse model, that same single treatment significantly reduced disease recurrence. These findings suggest HDF spheroids may provide a durable response with fewer administrations compared to current biologics.
FibroBiologics plans to expand this work by testing repeated dosing, analyzing systemic and local cytokine profiles, and conducting histopathology of skin lesions to understand how HDF spheroids work. The company believes these IND-enabling results mark a pivotal step toward a scalable, durable therapy for chronic inflammatory diseases. Ultimately, it aims to develop a single HDF spheroid treatment that offers long-term protection against psoriasis relapse, shifting the treatment paradigm for millions of patients.
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FibroBiologics FDA Events - Frequently Asked Questions
As of now, FibroBiologics (FBLG) has not received any FDA approvals for its therapy in the last two years.
In the past two years, FibroBiologics (FBLG) has reported FDA regulatory activity for Human dermal fibroblast.
The most recent FDA-related event for FibroBiologics occurred on September 11, 2025, involving Human dermal fibroblast. The update was categorized as "Positive Data," with the company reporting: "FibroBiologics, Inc. announced positive IND-enabling updates from its psoriasis research program demonstrating the potential of human dermal fibroblast (HDF) spheroids as a novel therapeutic approach for chronic-relapse psoriasis."
Currently, FibroBiologics has one therapy (Human dermal fibroblast) targeting the following condition: in Chronic-Relapse Psoriasis Treatment.
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:FBLG) was last updated on 9/12/2025 by MarketBeat.com Staff
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