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Cardinal Health (CAH) FDA Events

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FDA Events for Cardinal Health (CAH)

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.

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 February 26, 2025, involving TLX250-CDx. The update was categorized as "PDUFA Date," with the company reporting: "Telix today announces that PDUFA[3] date of 27 August 2025"

Currently, Cardinal Health has one therapy (TLX250-CDx) targeting the following condition: For the imaging of kidney cancer.

More FDA Event Resources from MarketBeat

  • 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 7/10/2025 by MarketBeat.com Staff
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