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Biodesix (BDSX) FDA Events

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FDA Events for Biodesix (BDSX)

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

Biodesix's Drugs in FDA Review

Nodify CDT® - FDA Regulatory Timeline and Events

Nodify CDT® is a drug developed by Biodesix for the following indication: blood-based lung nodule test. 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.

Nodify XL2 - FDA Regulatory Timeline and Events

Nodify XL2 is a drug developed by Biodesix for the following indication: For patients with lung 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.

Biodesix FDA Events - Frequently Asked Questions

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

In the past two years, Biodesix (BDSX) has reported FDA regulatory activity for the following drugs: Nodify CDT® and Nodify XL2.

The most recent FDA-related event for Biodesix occurred on January 7, 2025, involving Nodify CDT®. The update was categorized as "Publication," with the company reporting: "Biodesix, Inc. announced a new post-market clinical validation study was published in CHEST Pulmonary Journal that reaffirms the previously established performance of the Nodify CDT® blood-based lung nodule test."

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

  • blood-based lung nodule test. - Nodify CDT®
  • For patients with lung diseases. - Nodify XL2

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