This company has been marked as potentially delisted and may not be actively trading. Hologic (HOLX) FDA Approvals Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsEarningsFDA EventsHeadlinesInsider TradesOwnershipShort InterestTrendsBuy This Stock Hologic's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Hologic (HOLX). Over the past two years, Hologic has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Panther. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. FDA Regulatory Events Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. is a drug developed by Hologic for the following indication: Detect Common Causes of Infectious Gastroenteritis. 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. FDA Clearance - October 2,2025Fda Clearance Drug: Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays.Announced Date: October 2, 2025Indication: Detect Common Causes of Infectious GastroenteritisAnnouncementHologic, Inc announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays.AI SummaryHologic, Inc. announced that the U.S. Food and Drug Administration has granted 510(k) clearance for its Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. These new molecular tests are designed to quickly detect the most common bacterial causes of infectious gastroenteritis, such as Salmonella, Campylobacter, Shigella, E. coli (including O157), Vibrio, Yersinia and Plesiomonas. The assays can be run together or in any combination, letting laboratories tailor testing panels to each patient’s needs. This mini-panel approach helps reduce unnecessary tests, streamlines workflows and speeds up time to diagnosis. By providing fast, accurate results, the assays support informed clinical decisions and antimicrobial stewardship, ensuring antibiotics are used only when needed. Testing is performed on Hologic’s fully automated Panther Fusion System, which integrates easily into existing lab operations. This clearance highlights Hologic’s commitment to advancing diagnostic innovation and raising the standard of care for patients with suspected bacterial GI infections.Read Announcement Hologic FDA Events - Frequently Asked Questions Has Hologic received FDA approval? As of now, Hologic (HOLX) has not received any FDA approvals for its therapy in the last two years. What drugs has Hologic submitted to the FDA? In the past two years, Hologic (HOLX) has reported FDA regulatory activity for Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays.. What is the most recent FDA event for Hologic? The most recent FDA-related event for Hologic occurred on October 2, 2025, involving Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays.. The update was categorized as "FDA Clearance," with the company reporting: "Hologic, Inc announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays." What conditions do Hologic's current drugs treat? Currently, Hologic has one therapy (Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays.) targeting the following condition: Detect Common Causes of Infectious Gastroenteritis. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Axsome Therapeutics FDA EventsBiogen FDA EventsFate Therapeutics FDA EventsGH Research FDA EventsIncyte FDA EventsJazz Pharmaceuticals FDA EventsMoleculin Biotech FDA EventsMirum Pharmaceuticals FDA EventsNextCure FDA EventsPharming Group FDA EventsRegeneron Pharmaceuticals FDA Eventsargenex FDA EventsCabaletta Bio FDA EventsDyne Therapeutics FDA EventsFibroBiologics 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 Related Companies Merit Medical Systems FDA Events Zimmer Biomet FDA Events Becton, Dickinson and Company FDA Events DexCom FDA Events Insulet FDA Events Teleflex FDA Events AtriCure FDA Events AngioDynamics FDA Events Medtronic FDA Events Boston Scientific FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:HOLX last updated on 10/2/2025 by MarketBeat.com Staff. 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FDA Clearance - October 2,2025Fda Clearance Drug: Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays.Announced Date: October 2, 2025Indication: Detect Common Causes of Infectious GastroenteritisAnnouncementHologic, Inc announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays.AI SummaryHologic, Inc. announced that the U.S. Food and Drug Administration has granted 510(k) clearance for its Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. These new molecular tests are designed to quickly detect the most common bacterial causes of infectious gastroenteritis, such as Salmonella, Campylobacter, Shigella, E. coli (including O157), Vibrio, Yersinia and Plesiomonas. The assays can be run together or in any combination, letting laboratories tailor testing panels to each patient’s needs. This mini-panel approach helps reduce unnecessary tests, streamlines workflows and speeds up time to diagnosis. By providing fast, accurate results, the assays support informed clinical decisions and antimicrobial stewardship, ensuring antibiotics are used only when needed. Testing is performed on Hologic’s fully automated Panther Fusion System, which integrates easily into existing lab operations. This clearance highlights Hologic’s commitment to advancing diagnostic innovation and raising the standard of care for patients with suspected bacterial GI infections.Read Announcement
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