QuidelOrtho (QDEL) FDA Approvals $14.49 -0.25 (-1.70%) Closing price 04:00 PM EasternExtended Trading$14.49 0.00 (0.00%) As of 04:41 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsInsider TradesNews and TrendsOptions ChainOwnershipSEC FilingsShort Interest QuidelOrtho's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by QuidelOrtho (QDEL). Over the past two years, QuidelOrtho has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ORTHO. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. ORTHO VISION FDA Regulatory Events ORTHO VISION is a drug developed by QuidelOrtho for the following indication: for patients who depend on timely transfusion decisions. 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. Highlights - October 16,2025Highlights Drug: ORTHO VISIONAnnounced Date: October 16, 2025Indication: for patients who depend on timely transfusion decisions.AnnouncementQuidelOrtho Corporation will highlight its ongoing commitment to transfusion medicine excellence at the Association for the Advancement of Blood & Biotherapies (AABB) 2025 Annual Meeting.AI SummaryQuidelOrtho Corporation will showcase its dedication to transfusion medicine excellence at the Association for the Advancement of Blood & Biotherapies (AABB) 2025 Annual Meeting. The company will spotlight its Micro Typing Systems (MTS) DAT Card paired with the ORTHO VISION™ Platform, combining column agglutination technology with advanced software features like reflex testing and on-demand quality control. Attendees can join hands-on product demonstrations of the ORTHO VISION Max Swift Analyzer for high-throughput labs and the ORTHO VISION Swift Analyzer for consistent, walk-away automation. QuidelOrtho will also present poster sessions on gel card performance and lab instrumentation reliability. In addition, educational talks will cover challenges in Rh(D) antigen typing, managing daratumumab interference, and resolving complex serological cases. QuidelOrtho invites blood bank professionals to explore new tools and register to learn how these solutions can improve efficiency and patient outcomes.Read Announcement QuidelOrtho FDA Events - Frequently Asked Questions Has QuidelOrtho received FDA approval? As of now, QuidelOrtho (QDEL) has not received any FDA approvals for its therapy in the last two years. What drugs has QuidelOrtho submitted to the FDA? In the past two years, QuidelOrtho (QDEL) has reported FDA regulatory activity for ORTHO VISION. What is the most recent FDA event for QuidelOrtho? The most recent FDA-related event for QuidelOrtho occurred on October 16, 2025, involving ORTHO VISION. The update was categorized as "Highlights," with the company reporting: "QuidelOrtho Corporation will highlight its ongoing commitment to transfusion medicine excellence at the Association for the Advancement of Blood & Biotherapies (AABB) 2025 Annual Meeting." What conditions do QuidelOrtho's current drugs treat? Currently, QuidelOrtho has one therapy (ORTHO VISION) targeting the following condition: for patients who depend on timely transfusion decisions.. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events ACADIA Pharmaceuticals FDA EventsBriacell Therap FDA EventsBiomea Fusion FDA EventsCapricor Therapeutics FDA EventsPrecision BioSciences FDA EventsErasca FDA EventsGilead Sciences FDA EventsMonte Rosa Therapeutics FDA EventsInsmed FDA EventsLiminatus Pharma FDA EventsPTC Therapeutics FDA EventsREGENXBIO FDA EventsRhythm Pharmaceuticals FDA EventsTiziana Life Sciences FDA EventsUnited Therapeutics 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 Sanara MedTech FDA Events Align Technology FDA Events Pulse Biosciences FDA Events TransMedics Group FDA Events AxoGen FDA Events NovoCure FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:QDEL last updated on 10/17/2025 by MarketBeat.com Staff. 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Highlights - October 16,2025Highlights Drug: ORTHO VISIONAnnounced Date: October 16, 2025Indication: for patients who depend on timely transfusion decisions.AnnouncementQuidelOrtho Corporation will highlight its ongoing commitment to transfusion medicine excellence at the Association for the Advancement of Blood & Biotherapies (AABB) 2025 Annual Meeting.AI SummaryQuidelOrtho Corporation will showcase its dedication to transfusion medicine excellence at the Association for the Advancement of Blood & Biotherapies (AABB) 2025 Annual Meeting. The company will spotlight its Micro Typing Systems (MTS) DAT Card paired with the ORTHO VISION™ Platform, combining column agglutination technology with advanced software features like reflex testing and on-demand quality control. Attendees can join hands-on product demonstrations of the ORTHO VISION Max Swift Analyzer for high-throughput labs and the ORTHO VISION Swift Analyzer for consistent, walk-away automation. QuidelOrtho will also present poster sessions on gel card performance and lab instrumentation reliability. In addition, educational talks will cover challenges in Rh(D) antigen typing, managing daratumumab interference, and resolving complex serological cases. QuidelOrtho invites blood bank professionals to explore new tools and register to learn how these solutions can improve efficiency and patient outcomes.Read Announcement
