Free Trial

Smith & Nephew SNATS (SNN) FDA Events

Smith & Nephew SNATS logo
$30.74 +0.97 (+3.26%)
Closing price 03:57 PM Eastern
Extended Trading
$30.69 -0.05 (-0.16%)
As of 06:04 PM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.
FDA Events for Smith & Nephew SNATS (SNN)

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

Smith & Nephew SNATS's Drugs in FDA Review

CATALYSTEM - FDA Regulatory Timeline and Events

CATALYSTEM is a drug developed by Smith & Nephew SNATS for the following indication: Primary Hip System. 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.

LEGION Hinged Knee (HK) System - FDA Regulatory Timeline and Events

LEGION Hinged Knee (HK) System is a drug developed by Smith & Nephew SNATS for the following indication: To provide a natural range of motion with medial pivot, lateral roll back, and screw home. 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.

Smith & Nephew SNATS FDA Events - Frequently Asked Questions

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

In the past two years, Smith & Nephew SNATS (SNN) has reported FDA regulatory activity for the following drugs: LEGION Hinged Knee (HK) System and CATALYSTEM.

The most recent FDA-related event for Smith & Nephew SNATS occurred on October 2, 2024, involving LEGION Hinged Knee (HK) System. The update was categorized as "Provided Update," with the company reporting: "Smith+Nephew announced that that its LEGION Hinged Knee (HK) System is now available in the United States with proprietary OXINIUM (Oxidized Zirconium) implant technology that delivers the durability of metals, the wear resistance of ceramics, and corrosion resistance better than both.1-11"

Current therapies from Smith & Nephew SNATS in review with the FDA target conditions such as:

  • To provide a natural range of motion with medial pivot, lateral roll back, and screw home. - LEGION Hinged Knee (HK) System
  • Primary Hip System. - CATALYSTEM

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:SNN) was last updated on 7/9/2025 by MarketBeat.com Staff
From Our Partners