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Evolus (EOLS) FDA Events

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FDA Events for Evolus (EOLS)

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

Evolus' Drugs in FDA Review

Evolysse™ - FDA Regulatory Timeline and Events

Evolysse™ is a drug developed by Evolus for the following indication: Evolus dermal filler. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Jeuveau - FDA Regulatory Timeline and Events

Jeuveau is a drug developed by Evolus for the following indication: Aesthetics. 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.

Nuceiva® - FDA Regulatory Timeline and Events

Nuceiva® is a drug developed by Evolus for the following indication: For the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients2. 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.

Evolus FDA Events - Frequently Asked Questions

Yes, Evolus (EOLS) has received FDA approval for Evolysse™. This page tracks recent and historical FDA regulatory events related to Evolus' drug portfolio.

In the past two years, Evolus (EOLS) has reported FDA regulatory activity for the following drugs: Evolysse™, Nuceiva® and Jeuveau.

The most recent FDA-related event for Evolus occurred on July 9, 2025, involving Nuceiva®. The update was categorized as "Provided Update," with the company reporting: "Evolus, Inc announced it has partnered with Symatese to commence distribution of Nuceiva® (botulinum toxin type A) in France."

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

  • Evolus dermal filler, - Evolysse™
  • For the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients2. - Nuceiva®
  • Aesthetics - Jeuveau

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:EOLS) was last updated on 7/9/2025 by MarketBeat.com Staff
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