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Teleflex (TFX) FDA Events

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FDA Events for Teleflex (TFX)

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

Teleflex's Drugs in FDA Review

QuikClot Control+ - FDA Regulatory Timeline and Events

QuikClot Control+ is a drug developed by Teleflex for the following indication: Device to of internal and external bleeding. 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.

Titan SGS - FDA Regulatory Timeline and Events

Titan SGS is a drug developed by Teleflex for the following indication: laparoscopic sleeve gastrectomy. 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.

UroLift - FDA Regulatory Timeline and Events

UroLift is a drug developed by Teleflex for the following indication: Men with benign prostatic hyperplasia (BPH). 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.

Teleflex FDA Events - Frequently Asked Questions

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

In the past two years, Teleflex (TFX) has reported FDA regulatory activity for the following drugs: UroLift, Titan SGS and QuikClot Control+.

The most recent FDA-related event for Teleflex occurred on May 15, 2025, involving UroLift. The update was categorized as "Presentation," with the company reporting: "Teleflex Incorporated announced the presentation of compelling new clinical data at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, held April 26–29. Data from two randomized controlled trials (RCTs) reinforce the UroLift™ System's advantages compared with Rezūm and tamsulosin, particularly in terms of early patient satisfaction, rapid symptom relief, and sexual function outcomes.1-2"

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

  • Men with benign prostatic hyperplasia (BPH) - UroLift
  • laparoscopic sleeve gastrectomy - Titan SGS
  • Device to of internal and external bleeding. - QuikClot Control+

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 (NYSE:TFX) was last updated on 7/10/2025 by MarketBeat.com Staff
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