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Apyx Medical (APYX) FDA Events

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FDA Events for Apyx Medical (APYX)

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

Renuvion - FDA Regulatory Timeline and Events

Renuvion is a drug developed by Apyx Medical for the following indication: Contracting subcutaneous soft tissue following liposuction in multiple areas of the body. 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.

Apyx Medical FDA Events - Frequently Asked Questions

As of now, Apyx Medical (APYX) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Apyx Medical (APYX) has reported FDA regulatory activity for Renuvion.

The most recent FDA-related event for Apyx Medical occurred on January 6, 2025, involving Renuvion. The update was categorized as "Provided Update," with the company reporting: "Apyx® Medical announce it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (the "FDA") for the AYON Body Contouring System."

Currently, Apyx Medical has one therapy (Renuvion) targeting the following condition: Contracting subcutaneous soft tissue following liposuction in multiple areas of the body.

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