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TG Therapeutics (TGTX) FDA Events

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FDA Events for TG Therapeutics (TGTX)

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

TG Therapeutics' Drugs in FDA Review

BRIUMVI - FDA Regulatory Timeline and Events

BRIUMVI is a drug developed by TG Therapeutics for the following indication: For the management of autoimmune disorders. 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.

BRIUMVI® (ublituximab-xiiy) - FDA Regulatory Timeline and Events

BRIUMVI® (ublituximab-xiiy) is a drug developed by TG Therapeutics for the following indication: For treat relapsing forms of multiple sclerosis (MS). 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.

TG 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, TG Therapeutics (TGTX) has reported FDA regulatory activity for the following drugs: BRIUMVI and BRIUMVI® (ublituximab-xiiy).

The most recent FDA-related event for TG Therapeutics occurred on May 30, 2025, involving BRIUMVI. The update was categorized as "Presentation," with the company reporting: "TG Therapeutics, Inc. announced the presentations of data highlighting BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. Links to each presentation are included below."

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

  • For the management of autoimmune disorders - BRIUMVI
  • For treat relapsing forms of multiple sclerosis (MS). - BRIUMVI® (ublituximab-xiiy)

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