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Pacira BioSciences (PCRX) FDA Events

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FDA Events for Pacira BioSciences (PCRX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Pacira BioSciences (PCRX). Over the past two years, Pacira BioSciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as iovera° and PCRX-201. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Pacira BioSciences' Drugs in FDA Review

iovera° - FDA Regulatory Timeline and Events

iovera° is a drug developed by Pacira BioSciences for the following indication: drug-free treatment that relieves pain via cryoneurolysis. 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.

PCRX-201 - FDA Regulatory Timeline and Events

PCRX-201 is a drug developed by Pacira BioSciences for the following indication: For the Treatment of Osteoarthritis of the Knee. 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.

Pacira BioSciences FDA Events - Frequently Asked Questions

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

In the past two years, Pacira BioSciences (PCRX) has reported FDA regulatory activity for the following drugs: PCRX-201 and iovera°.

The most recent FDA-related event for Pacira BioSciences occurred on June 11, 2025, involving PCRX-201. The update was categorized as "Follow-up data," with the company reporting: "Pacira BioSciences, Inc announced new long-term follow-up data from its Phase 1 clinical trial evaluating PCRX-201 (enekinragene inzadenovec), a novel gene therapy candidate for osteoarthritis of the knee."

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

  • For the Treatment of Osteoarthritis of the Knee - PCRX-201
  • drug-free treatment that relieves pain via cryoneurolysis - iovera°

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