FDA Events for Clarivate (CLVT)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Clarivate (CLVT).
Over the past two years, Clarivate has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
OFF-X™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
OFF-X™ - FDA Regulatory Timeline and Events
OFF-X™ is a drug developed by Clarivate for the following indication: For Preclinical and Clinical Safety Intelligence.
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:
- OFF-X™
- Announced Date:
- July 30, 2024
- Indication:
- For Preclinical and Clinical Safety Intelligence
Announcement
Clarivate Plc announced the launch of the new OFF-X™ platform.
AI Summary
Clarivate Plc has launched its new OFF-X™ platform, a cutting-edge safety intelligence tool designed for the biopharma industry. This innovative platform provides a seamless user experience by offering quick searches, clear visual designs, and a suite of analytical tools that help users identify and manage drug safety risks. OFF-X™ is fully integrated with Cortellis Drug Discovery Intelligence™, forming a one-stop resource for safety data, which is essential for tracking both preclinical and post-marketing phases of drug development.
Key improvements include an upgraded technology stack that reduced loading times by 80%, enabling faster access to detailed information on drugs, targets, and adverse events. The platform offers enhanced visualizations and robust analytics, empowering researchers and companies to make confident, well-informed decisions in drug research and development.
Read Announcement
Clarivate FDA Events - Frequently Asked Questions
As of now, Clarivate (CLVT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Clarivate (CLVT) has reported FDA regulatory activity for OFF-X™.
The most recent FDA-related event for Clarivate occurred on July 30, 2024, involving OFF-X™. The update was categorized as "Provided Update," with the company reporting: "Clarivate Plc announced the launch of the new OFF-X™ platform."
Currently, Clarivate has one therapy (OFF-X™) targeting the following condition: For Preclinical and Clinical Safety Intelligence.
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:CLVT) was last updated on 7/10/2025 by MarketBeat.com Staff
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