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Redhill Biopharma (RDHL) FDA Events

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FDA Events for Redhill Biopharma (RDHL)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Redhill Biopharma (RDHL). Over the past two years, Redhill Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Opaganib, Opaganib, RHB-102, RHB-104, RHB-107, Talicia, and Talicia. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Redhill Biopharma's Drugs in FDA Review

Opaganib - FDA Regulatory Timeline and Events

Opaganib is a drug developed by Redhill Biopharma for the following indication: Severe COVID-19 pneumonia. 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.

Opaganib (Yeliva, ABC294640) - FDA Regulatory Timeline and Events

Opaganib (Yeliva, ABC294640) is a drug developed by Redhill Biopharma for the following indication: COVID-19 variants. 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.

RHB-102 - FDA Regulatory Timeline and Events

RHB-102 is a drug developed by Redhill Biopharma for the following indication: Relief from nausea and vomiting symptoms. 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.

RHB-104 - FDA Regulatory Timeline and Events

RHB-104 is a drug developed by Redhill Biopharma for the following indication: In Crohn's Disease. 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.

RHB-107 - FDA Regulatory Timeline and Events

RHB-107 is a drug developed by Redhill Biopharma for the following indication: Non-Hospitalized COVID-19. 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.

Talicia - FDA Regulatory Timeline and Events

Talicia is a drug developed by Redhill Biopharma for the following indication: Low-dose rifabutin. 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.

Talicia (RHB-105) - FDA Regulatory Timeline and Events

Talicia (RHB-105) is a drug developed by Redhill Biopharma for the following indication: H. pylori. 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.

Redhill Biopharma FDA Events - Frequently Asked Questions

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

In the past two years, Redhill Biopharma (RDHL) has reported FDA regulatory activity for the following drugs: Opaganib, Talicia, RHB-104, RHB-107, RHB-102, Talicia (RHB-105) and Opaganib (Yeliva, ABC294640).

The most recent FDA-related event for Redhill Biopharma occurred on July 1, 2025, involving Opaganib. The update was categorized as "Provided Update," with the company reporting: "RedHill Biopharma Ltd announced the initiation of patient recruitment into the Phase 2 study evaluating the efficacy of opaganib3 in combination with darolutamide4 in men with metastatic castrate-resistant prostate cancer (mCRPC), sponsored by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group Ltd."

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

  • Severe COVID-19 pneumonia - Opaganib
  • Low-dose rifabutin - Talicia
  • In Crohn's Disease - RHB-104
  • Non-Hospitalized COVID-19 - RHB-107
  • Relief from nausea and vomiting symptoms - RHB-102
  • H. pylori - Talicia (RHB-105)
  • COVID-19 variants - Opaganib (Yeliva, ABC294640)

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