Free Trial

Heron Therapeutics (HRTX) FDA Events

Heron Therapeutics logo
$2.23 +0.03 (+1.36%)
Closing price 07/9/2025 04:00 PM Eastern
Extended Trading
$2.18 -0.04 (-2.02%)
As of 04:24 AM 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 Heron Therapeutics (HRTX)

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

ZYNRELEF (bupivacaine and meloxicam HTX-011) - FDA Regulatory Timeline and Events

ZYNRELEF (bupivacaine and meloxicam HTX-011) is a drug developed by Heron Therapeutics for the following indication: Postoperative pain. 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.

Heron Therapeutics FDA Events - Frequently Asked Questions

As of now, Heron Therapeutics (HRTX) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Heron Therapeutics (HRTX) has reported FDA regulatory activity for ZYNRELEF (bupivacaine and meloxicam HTX-011).

The most recent FDA-related event for Heron Therapeutics occurred on September 25, 2024, involving ZYNRELEF (bupivacaine and meloxicam HTX-011). The update was categorized as "FDA Approval," with the company reporting: "Heron Therapeutics, Inc. announced that the U.S. Food and Drug Administration (the "FDA") has approved the Company's Prior Approval Supplement Application for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution VAN."

Currently, Heron Therapeutics has one therapy (ZYNRELEF (bupivacaine and meloxicam HTX-011)) targeting the following condition: Postoperative pain.

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:HRTX) was last updated on 7/10/2025 by MarketBeat.com Staff
From Our Partners