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Greenwich LifeSciences (GLSI) FDA Events

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FDA Events for Greenwich LifeSciences (GLSI)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Greenwich LifeSciences (GLSI). Over the past two years, Greenwich LifeSciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as GLSI-100. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

GLSI-100 - FDA Regulatory Timeline and Events

GLSI-100 is a drug developed by Greenwich LifeSciences for the following indication: Breast cancer recurrences. 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.

Greenwich LifeSciences FDA Events - Frequently Asked Questions

As of now, Greenwich LifeSciences (GLSI) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Greenwich LifeSciences (GLSI) has reported FDA regulatory activity for GLSI-100.

The most recent FDA-related event for Greenwich LifeSciences occurred on April 3, 2025, involving GLSI-100. The update was categorized as "Provided Update," with the company reporting: "Greenwich Lifesciences Provides Update On Its Phase III Clinical Trial, Flamingo-01, Which Is Evaluating GLSI-100, An Immunotherapy To Prevent Breast Cancer Recurrences"

Currently, Greenwich LifeSciences has one therapy (GLSI-100) targeting the following condition: Breast cancer recurrences.

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:GLSI) was last updated on 7/11/2025 by MarketBeat.com Staff
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