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Aurinia Pharmaceuticals (AUPH) FDA Events

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FDA Events for Aurinia Pharmaceuticals (AUPH)

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

Aurinia Pharmaceuticals' Drugs in FDA Review

AUR 200 - FDA Regulatory Timeline and Events

AUR 200 is a drug developed by Aurinia Pharmaceuticals for the following indication: For B-cell mediated autoimmune diseases. 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.

LUPKYNIS (voclosporin) - FDA Regulatory Timeline and Events

LUPKYNIS (voclosporin) is a drug developed by Aurinia Pharmaceuticals for the following indication: Lupus Nephritis. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Aurinia Pharmaceuticals FDA Events - Frequently Asked Questions

Yes, Aurinia Pharmaceuticals (AUPH) has received FDA approval for LUPKYNIS (voclosporin). This page tracks recent and historical FDA regulatory events related to Aurinia Pharmaceuticals' drug portfolio.

In the past two years, Aurinia Pharmaceuticals (AUPH) has reported FDA regulatory activity for the following drugs: LUPKYNIS (voclosporin) and AUR 200.

The most recent FDA-related event for Aurinia Pharmaceuticals occurred on June 29, 2025, involving AUR 200. The update was categorized as "Provided Update," with the company reporting: "Aurinia Pharmaceuticals Inc announced that it will host a webcast and conference call on June 30, 2025, at 8:30 a.m. ET to discuss AUR200 Phase 1 study results."

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

  • Lupus Nephritis - LUPKYNIS (voclosporin)
  • For B-cell mediated autoimmune diseases. - AUR 200

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