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RenovoRx (RNXT) FDA Approvals

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RenovoRx's Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by RenovoRx (RNXT). Over the past two years, RenovoRx has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as TIGeR-PaC, RenovoCath, and TAMP. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

TIGeR-PaC FDA Regulatory Timeline and Events

TIGeR-PaC is a drug developed by RenovoRx for the following indication: To provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT). 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.

RenovoCath FDA Regulatory Timeline and Events

RenovoCath is a drug developed by RenovoRx for the following indication: Solid Tumors. 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.

TAMP FDA Regulatory Events

TAMP is a drug developed by RenovoRx for the following indication: For the treatment of locally advanced pancreatic 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.

RenovoRx FDA Events - Frequently Asked Questions

In the past two years, RenovoRx (RNXT) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, RenovoRx (RNXT) has reported FDA regulatory activity for the following drugs: RenovoCath, TIGeR-PaC and TAMP.

The most recent FDA-related event for RenovoRx occurred on August 25, 2026, involving TIGeR-PaC. The update was categorized as "Publication," with the company reporting: "RenovoRx, Inc. announced the publication of pharmacokinetic and pharmacodynamic (PK/PD) data from a sub-study of its ongoing Phase III TIGeR-PaC clinical trial (NCT03257033) in the journal Cancer Chemotherapy and Pharmacology."

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

  • Solid Tumors - RenovoCath
  • To provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT). - TIGeR-PaC
  • For the treatment of locally advanced pancreatic cancer - TAMP
  • 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

FDA progress for NASDAQ:RNXT last updated on 8/25/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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