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NovoCure (NVCR) FDA Events

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FDA Events for NovoCure (NVCR)

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

NovoCure's Drugs in FDA Review

Optune Lua - FDA Regulatory Timeline and Events

Optune Lua is a drug developed by NovoCure for the following indication: For the Treatment of Metastatic Non-Small Cell Lung Cancer. 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.

Tumor Treating Fields - PANOVA-3 - FDA Regulatory Timeline and Events

Tumor Treating Fields - PANOVA-3 is a drug developed by NovoCure for the following indication: Locally advanced pancreatic cancer. 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.

NovoCure FDA Events - Frequently Asked Questions

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

In the past two years, NovoCure (NVCR) has reported FDA regulatory activity for the following drugs: Tumor Treating Fields - PANOVA-3 and Optune Lua.

The most recent FDA-related event for NovoCure occurred on July 1, 2025, involving Tumor Treating Fields - PANOVA-3. The update was categorized as "Results," with the company reporting: "Novocure announced that it will present the final secondary endpoint results from the Phase 3 PANOVA-3 trial of its Tumor Treating Fields (TTFields) therapy for unresectable, locally advanced pancreatic cancer."

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

  • Locally advanced pancreatic cancer - Tumor Treating Fields - PANOVA-3
  • For the Treatment of Metastatic Non-Small Cell Lung Cancer - Optune Lua

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