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Panbela Therapeutics (PBLA) FDA Events

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FDA Events for Panbela Therapeutics (PBLA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Panbela Therapeutics (PBLA). Over the past two years, Panbela Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as eflornithine, ivospemin, and SBP-101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Panbela Therapeutics' Drugs in FDA Review

eflornithine - FDA Regulatory Timeline and Events

eflornithine is a drug developed by Panbela Therapeutics for the following indication: in Patients with Gastric Premalignant Conditions. 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.

ivospemin - FDA Regulatory Timeline and Events

ivospemin is a drug developed by Panbela Therapeutics for the following indication: 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.

SBP-101 - FDA Regulatory Timeline and Events

SBP-101 is a drug developed by Panbela Therapeutics for the following indication: 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.

Panbela Therapeutics FDA Events - Frequently Asked Questions

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

In the past two years, Panbela Therapeutics (PBLA) has reported FDA regulatory activity for the following drugs: ivospemin, SBP-101 and eflornithine.

The most recent FDA-related event for Panbela Therapeutics occurred on June 24, 2024, involving ivospemin. The update was categorized as "Regulatory Update," with the company reporting: "Panbela Therapeutics, Inc announced that the independent Data Safety Monitoring Board (DSMB) has completed its third pre-specified safety review of the ongoing Phase 3 ASPIRE clinical trial evaluating ivospemin in combination with gemcitabine and nab-Paclitaxel for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC).."

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

  • Pancreatic Cancer - ivospemin
  • Pancreatic Cancer - SBP-101
  • in Patients with Gastric Premalignant Conditions - eflornithine

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:PBLA) was last updated on 7/10/2025 by MarketBeat.com Staff
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