Tempus AI's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Tempus AI (TEM).
Over the past two years, Tempus AI has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
xT. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
XT CDx FDA Regulatory Events
XT CDx is a drug developed by Tempus AI for the following indication: For colorectal cancer patients.
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:
- xT CDx
- Announced Date:
- January 15, 2025
- Indication:
- For colorectal cancer patients
Announcement
Tempus AI, Inc announced the national launch of the company's FDA-approved, NGS-based in vitro diagnostic device, xT CDx. Beginning today, xT CDx is now available for all ordering clinicians nationwide.
AI Summary
Tempus AI, Inc has launched its FDA-approved, next-generation sequencing in vitro diagnostic device, xT CDx, now available nationwide for all ordering clinicians. This new test uses one of the largest reported gene panels, analyzing 648 genes to provide comprehensive tumor profiling, including microsatellite instability status and essential companion diagnostic information for cancer treatment decisions.
Utilizing a normal-matched approach, xT CDx sequences both tumor and normal patient samples simultaneously to offer more accurate detection of cancer-driving genetic alterations. The test supports clinicians in making informed, precise treatment choices for patients with solid tumors. With its national launch, Tempus aims to broaden access to high-quality genomic insights and further advance precision medicine in everyday patient care.
Read Announcement
Tempus AI FDA Events - Frequently Asked Questions
As of now, Tempus AI (TEM) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Tempus AI (TEM) has reported FDA regulatory activity for xT CDx.
The most recent FDA-related event for Tempus AI occurred on January 15, 2025, involving xT CDx. The update was categorized as "Provided Update," with the company reporting: "Tempus AI, Inc announced the national launch of the company's FDA-approved, NGS-based in vitro diagnostic device, xT CDx. Beginning today, xT CDx is now available for all ordering clinicians nationwide."
Currently, Tempus AI has one therapy (xT CDx) targeting the following condition: For colorectal cancer patients.
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:TEM) was last updated on 7/16/2025 by MarketBeat.com Staff
