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Cardiff Oncology (CRDF) FDA Events

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FDA Events for Cardiff Oncology (CRDF)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Cardiff Oncology (CRDF). Over the past two years, Cardiff Oncology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CRDF-004 and onvansertib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Cardiff Oncology's Drugs in FDA Review

CRDF-004 - FDA Regulatory Timeline and Events

CRDF-004 is a drug developed by Cardiff Oncology for the following indication: RAS-mutated mCRC. 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.

onvansertib + paclitaxel - FDA Regulatory Timeline and Events

onvansertib + paclitaxel is a drug developed by Cardiff Oncology for the following indication: In Metastatic Triple-Negative Breast 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.

Cardiff Oncology FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Cardiff Oncology (CRDF) has reported FDA regulatory activity for the following drugs: CRDF-004 and onvansertib + paclitaxel.

The most recent FDA-related event for Cardiff Oncology occurred on June 2, 2025, involving onvansertib + paclitaxel. The update was categorized as "Positive Data," with the company reporting: "Cardiff Oncology, Inc. announced positive data from an investigator-initiated Phase 1b clinical trial evaluating onvansertib in combination with paclitaxel in patients with metastatic triple-negative breast cancer (mTNBC) at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30-June 3, 2025, in Chicago, Illinois."

Current therapies from Cardiff Oncology in review with the FDA target conditions such as:

  • RAS-mutated mCRC. - CRDF-004
  • In Metastatic Triple-Negative Breast Cancer - onvansertib + paclitaxel

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 (NASDAQ:CRDF) was last updated on 7/10/2025 by MarketBeat.com Staff
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