FDA Events for Charles River Laboratories International (CRL)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Charles River Laboratories International (CRL).
Over the past two years, Charles River Laboratories International has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
FOXG1. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
FOXG1 - FDA Regulatory Timeline and Events
FOXG1 is a drug developed by Charles River Laboratories International for the following indication: Advance Rare Disease Gene Therapy Development.
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:
- FOXG1
- Announced Date:
- July 30, 2024
- Indication:
- Advance Rare Disease Gene Therapy Development
Announcement
Charles River Laboratories International, Inc announced today a collaboration with the FOXG1 Research Foundation (FRF) highlighting the patient advocacy group's model to independently drive drug development through the clinical phase.
AI Summary
Charles River Laboratories International, Inc. announced a new collaboration with the FOXG1 Research Foundation, a unique patient advocacy group that drives drug development independently. The FOXG1 Research Foundation is focused on advancing treatments for FOXG1 syndrome and related neurological disorders, which have significant unmet medical needs. Through this collaboration, Charles River will support FOXG1’s Phase I-II gene therapy clinical trials by providing high-quality plasmid DNA and GMP-grade AAV9 viral vectors. This support comes from Charles River’s advanced cell and gene therapy contract development and manufacturing capabilities, ensuring that the materials produced meet phase-appropriate standards. FOXG1’s independent model allows the advocacy group to operate like a virtual biotech, efficiently moving treatments forward despite limited investment. This partnership highlights a promising approach to rare disease drug development by uniting expert manufacturing services with innovative, patient-led research.
Read Announcement
Charles River Laboratories International FDA Events - Frequently Asked Questions
As of now, Charles River Laboratories International (CRL) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Charles River Laboratories International (CRL) has reported FDA regulatory activity for FOXG1.
The most recent FDA-related event for Charles River Laboratories International occurred on July 30, 2024, involving FOXG1. The update was categorized as "Provided Update," with the company reporting: "Charles River Laboratories International, Inc announced today a collaboration with the FOXG1 Research Foundation (FRF) highlighting the patient advocacy group's model to independently drive drug development through the clinical phase."
Currently, Charles River Laboratories International has one therapy (FOXG1) targeting the following condition: Advance Rare Disease Gene Therapy Development.
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 (NYSE:CRL) was last updated on 7/10/2025 by MarketBeat.com Staff
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