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Tiziana Life Sciences (TLSA) FDA Events

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FDA Events for Tiziana Life Sciences (TLSA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Tiziana Life Sciences (TLSA). Over the past two years, Tiziana Life Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as 18F-PBR06-PET and Foralumab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Tiziana Life Sciences' Drugs in FDA Review

18F-PBR06-PET - FDA Regulatory Timeline and Events

18F-PBR06-PET is a drug developed by Tiziana Life Sciences for the following indication: Treating Moderate Alzheimer'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.

Foralumab - FDA Regulatory Timeline and Events

Foralumab is a drug developed by Tiziana Life Sciences for the following indication: Crohn's disease with decreases in the classic side effects of cytokine release syndrome. 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.

Tiziana Life Sciences FDA Events - Frequently Asked Questions

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

In the past two years, Tiziana Life Sciences (TLSA) has reported FDA regulatory activity for the following drugs: Foralumab and 18F-PBR06-PET.

The most recent FDA-related event for Tiziana Life Sciences occurred on May 15, 2025, involving 18F-PBR06-PET. The update was categorized as "Publication," with the company reporting: "Tiziana Life Sciences, Ltd. announced the publication of a new study in the Journal of ‘Clinical Nuclear Medicine' demonstrating that intranasal administration of foralumab significantly dampened microglial activation in a 78-year old patient with moderate Alzheimer's disease (AD) treated as part of a Food and Drug Administration (FDA) expanded access program."

Current therapies from Tiziana Life Sciences in review with the FDA target conditions such as:

  • Crohn's disease with decreases in the classic side effects of cytokine release syndrome - Foralumab
  • Treating Moderate Alzheimer's Disease - 18F-PBR06-PET

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:TLSA) was last updated on 7/9/2025 by MarketBeat.com Staff
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