Cardinal Health's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Cardinal Health (CAH).
Over the past two years, Cardinal Health has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TLX250-CDx. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TLX250-CDx FDA Regulatory Timeline and Events
TLX250-CDx is a drug developed by Cardinal Health for the following indication: For the imaging of kidney cancer.
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:
- TLX250-CDx
- Announced Date:
- August 28, 2025
- Indication:
- For the imaging of kidney cancer
Announcement
Telix Pharmaceuticals Limited received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for TLX250-CDx (Zircaix, 89Zr-DFO girentuximab), an investigational PET2 agent for the diagnosis and characterization of renal masses as clear cell renal cell carcinoma (ccRCC).
AI Summary
Telix Pharmaceuticals received a Complete Response Letter (CRL) from the FDA for its Biologics License Application for TLX250-CDx (Zircaix, 89Zr-DFO girentuximab), a PET agent to diagnose clear cell renal cell carcinoma. The FDA cited deficiencies in Chemistry, Manufacturing, and Controls (CMC).
The agency requested additional data to show the material used in the ZIRCON Phase 3 trial matches the scaled-up commercial manufacturing process. It also issued Form 483 notices to two third-party manufacturing partners that must be resolved before resubmission.
Telix plans to request a Type A meeting with the FDA to address the deficiencies and agree on a new timeline. Meanwhile, the company will maintain patient access through its expanded access program.
TLX250-CDx holds Breakthrough Therapy and Priority Review status, and the CRL does not affect Telix’s 2025 revenue guidance. If approved, it would be the first PET-based diagnostic drug for kidney cancer in the U.S., enhancing Telix’s growth prospects.
Read Announcement- Drug:
- TLX250-CDx
- Announced Date:
- February 26, 2025
- Indication:
- For the imaging of kidney cancer
Announcement
Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its breakthrough investigational kidney cancer PET[1] imaging agent TLX250-CDx (Zircaix®[2], 89Zr-DFO-girentuximab)
Read Announcement- Drug:
- TLX250-CDx
- Announced Date:
- February 26, 2025
- Estimated Event Date Range:
- August 27, 2025 - August 27, 2025
- Target Action Date:
- August 27, 2025
- Indication:
- For the imaging of kidney cancer
Announcement
Telix today announces that PDUFA[3] date of 27 August 2025
Read Announcement- Drug:
- TLX250-CDx
- Announced Date:
- December 29, 2024
- Indication:
- For the imaging of kidney cancer
Announcement
Telix Pharmaceuticals Limited announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX250-CDx (Zircaix®1, 89Zr- girentuximab) kidney cancer imaging2.
AI Summary
Telix Pharmaceuticals Limited has submitted a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for its innovative product TLX250-CDx (Zircaix®), an investigational PET imaging agent that targets kidney cancer. Designed specifically for the non-invasive diagnosis and characterization of clear cell renal cell carcinoma (ccRCC) – the most common and aggressive form of kidney cancer – TLX250-CDx may become the first and only targeted PET agent for this purpose in the U.S.
With its Breakthrough designation, TLX250-CDx is set to receive priority review if approved. The FDA will undertake a 60-day administrative review and later set a goal date for further guidance. Telix aims to achieve a full U.S. commercial launch by 2025, providing a much-needed diagnostic tool for patients with suspected ccRCC.
Read Announcement- Drug:
- TLX250-CDx
- Announced Date:
- September 17, 2024
- Indication:
- For the imaging of kidney cancer
Announcement
Telix Pharmaceuticals Limited announces that it has selected Cardinal Health, Inc as a commercial radiopharmaceutical distributor to supply finished unit doses of its PET1 agent, Zircaix®2 (TLX250-CDx) for the imaging of kidney cancer in the United States (U.S.), subject to regulatory approval.
AI Summary
Telix Pharmaceuticals Limited has announced a new partnership with Cardinal Health, Inc. The company selected Cardinal Health as its commercial radiopharmaceutical distributor to supply finished unit doses of its PET imaging agent, Zircaix®2 (TLX250-CDx), which is designed for the non-invasive diagnosis of kidney cancer in the United States. The distribution plan is pending regulatory approval and aims to make Zircaix®2 available across a broad range of U.S. locations.
Telix intends to build on its existing relationship with Cardinal Health to maximize patient access to this breakthrough diagnostic tool. Cardinal Health, known for its extensive nuclear pharmacy network and flexible scheduling, will use its vast commercial infrastructure to ensure a reliable supply of Zircaix®2. This move is part of Telix’s efforts to expand and improve the accessibility of innovative imaging solutions for kidney cancer diagnosis.
Read Announcement
Cardinal Health FDA Events - Frequently Asked Questions
As of now, Cardinal Health (CAH) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Cardinal Health (CAH) has reported FDA regulatory activity for TLX250-CDx.
The most recent FDA-related event for Cardinal Health occurred on August 28, 2025, involving TLX250-CDx. The update was categorized as "Complete Response Letter," with the company reporting: "Telix Pharmaceuticals Limited received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for TLX250-CDx (Zircaix, 89Zr-DFO girentuximab), an investigational PET2 agent for the diagnosis and characterization of renal masses as clear cell renal cell carcinoma (ccRCC)."
Currently, Cardinal Health has one therapy (TLX250-CDx) targeting the following condition: For the imaging of kidney cancer.
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:CAH) was last updated on 9/11/2025 by MarketBeat.com Staff
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