Cardinal Health (CAH) FDA Approvals $196.92 +2.04 (+1.05%) As of 02:54 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsDividendEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Cardinal Health's Drug in the FDA Approval ProcessThis 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. Complete Response Letter - August 28,2025Complete Response Letter Drug: TLX250-CDxAnnounced Date: August 28, 2025Indication: For the imaging of kidney cancer AnnouncementTelix 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 SummaryTelix 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 AnnouncementPDUFA Date - February 26,2025Pdufa Date BLA Priority ReviewDrug: TLX250-CDxAnnounced Date: February 26, 2025Target Action Date: August 27, 2025Indication: For the imaging of kidney cancer AnnouncementTelix today announces that PDUFA[3] date of 27 August 2025Read AnnouncementFDA Accepted - February 26,2025Fda Accepted BLA Priority ReviewDrug: TLX250-CDxAnnounced Date: February 26, 2025Indication: For the imaging of kidney cancer AnnouncementTelix 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 AnnouncementBLA Filing - December 29,2024Bla Filing BLADrug: TLX250-CDxAnnounced Date: December 29, 2024Indication: For the imaging of kidney cancer AnnouncementTelix 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 SummaryTelix 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 AnnouncementProvided Update - September 17,2024Provided Update Drug: TLX250-CDxAnnounced Date: September 17, 2024Indication: For the imaging of kidney cancer AnnouncementTelix 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 SummaryTelix 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 Has Cardinal Health received FDA approval? As of now, Cardinal Health (CAH) has not received any FDA approvals for its therapy in the last two years. What drugs has Cardinal Health submitted to the FDA? In the past two years, Cardinal Health (CAH) has reported FDA regulatory activity for TLX250-CDx. What is the most recent FDA event for Cardinal Health? 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)." What conditions do Cardinal Health's current drugs treat? 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 Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events argenex FDA EventsAxsome Therapeutics FDA EventsBiogen FDA EventsCabaletta Bio FDA EventsDyne Therapeutics FDA EventsFibroBiologics FDA EventsIDEAYA Biosciences FDA EventsLexicon Pharmaceuticals FDA EventsMannKind FDA EventsInsulet FDA EventsTG Therapeutics FDA EventsTenaya Therapeutics FDA EventsJohnson & Johnson FDA EventsCandel Therapeutics FDA EventsCelcuity FDA Events 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 Related Companies DexCom FDA Events Merit Medical Systems FDA Events Haemonetics FDA Events Becton, Dickinson and Company FDA Events Align Technology FDA Events Amgen FDA Events Gilead Sciences FDA Events Abbott Laboratories FDA Events Pfizer FDA Events Bristol Myers Squibb FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NYSE:CAH last updated on 8/29/2025 by MarketBeat.com Staff. 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Complete Response Letter - August 28,2025Complete Response Letter Drug: TLX250-CDxAnnounced Date: August 28, 2025Indication: For the imaging of kidney cancer AnnouncementTelix 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 SummaryTelix 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
PDUFA Date - February 26,2025Pdufa Date BLA Priority ReviewDrug: TLX250-CDxAnnounced Date: February 26, 2025Target Action Date: August 27, 2025Indication: For the imaging of kidney cancer AnnouncementTelix today announces that PDUFA[3] date of 27 August 2025Read Announcement
FDA Accepted - February 26,2025Fda Accepted BLA Priority ReviewDrug: TLX250-CDxAnnounced Date: February 26, 2025Indication: For the imaging of kidney cancer AnnouncementTelix 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
BLA Filing - December 29,2024Bla Filing BLADrug: TLX250-CDxAnnounced Date: December 29, 2024Indication: For the imaging of kidney cancer AnnouncementTelix 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 SummaryTelix 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
Provided Update - September 17,2024Provided Update Drug: TLX250-CDxAnnounced Date: September 17, 2024Indication: For the imaging of kidney cancer AnnouncementTelix 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 SummaryTelix 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
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