Freenome (FRNM) FDA Approvals

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Freenome's Drug in the FDA Approval Process

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

SimpleScreen™ FDA Regulatory Events

SimpleScreen™ is a drug developed by Freenome for the following indication: Lung Cancer Screening 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.

Designation Grant

Breakthrough Device

Drug:: SimpleScreen™
Announced Date:: August 12, 2026
Indication:: Lung Cancer Screening Test

Announcement

Freenome, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to SimpleScreen™ Lung, the company’s investigational lung cancer screening test.

Read Announcement

Freenome FDA Events - Frequently Asked Questions

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

In the past two years, Freenome (FRNM) has reported FDA regulatory activity for SimpleScreen™.

The most recent FDA-related event for Freenome occurred on August 12, 2026, involving SimpleScreen™. The update was categorized as "Designation Grant," with the company reporting: "Freenome, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to SimpleScreen™ Lung, the company’s investigational lung cancer screening test."

Currently, Freenome has one therapy (SimpleScreen™) targeting the following condition: Lung Cancer Screening Test.

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FDA Event Stage Terminology & Abbreviation Guide

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

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FDA progress for NASDAQ:FRNM last updated on 8/12/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.

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Freenome (FRNM) FDA Approvals

Freenome's Drug in the FDA Approval Process