Freenome (FRNM) FDA Approvals $16.31 -0.59 (-3.49%) As of 04:00 PM Eastern Add Share Share FDA Events Stock AnalysisAnalyst ForecastsChartFDA EventsSEC Filings Freenome's Drug in the FDA Approval ProcessThis 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 - August 12,2026Designation Grant Breakthrough DeviceDrug: SimpleScreen™Announced Date: August 12, 2026Indication: Lung Cancer Screening TestAnnouncementFreenome, 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 Has Freenome received FDA approval? As of now, Freenome (FRNM) has not received any FDA approvals for its therapy in the last two years. What drugs has Freenome submitted to the FDA? In the past two years, Freenome (FRNM) has reported FDA regulatory activity for SimpleScreen™. What is the most recent FDA event for Freenome? 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." What conditions do Freenome's current drugs treat? Currently, Freenome has one therapy (SimpleScreen™) targeting the following condition: Lung Cancer Screening Test. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Rein Therapeutics FDA EventsBiogen FDA EventsC4 Therapeutics FDA EventsClimb Bio FDA EventsDyne Therapeutics FDA EventsHarmony Biosciences FDA EventsInsmed FDA EventsIonis Pharmaceuticals FDA EventsLiquidia FDA EventsMilestone Pharmaceuticals FDA EventsStoke Therapeutics FDA EventsAbbVie FDA EventsBridgeBio Pharma FDA EventsOpus Genetics FDA EventsuniQure FDA Events 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 Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:FRNM last updated on 8/12/2026 by MarketBeat.com Staff. 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Designation Grant - August 12,2026Designation Grant Breakthrough DeviceDrug: SimpleScreen™Announced Date: August 12, 2026Indication: Lung Cancer Screening TestAnnouncementFreenome, 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
