QuidelOrtho (QDEL) FDA Approvals $11.68 -0.10 (-0.83%) As of 10:28 AM Eastern This is a fair market value 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 Akebia Therapeutics FDA EventsBioNTech FDA EventsCullinan Therapeutics FDA EventsCorbus Pharmaceuticals FDA EventsDare Bioscience FDA EventsDefinium Therapeutics FDA EventsDogwood Therapeutics FDA EventsImmunocore FDA EventsJanux Therapeutics FDA EventsLipocine FDA EventsMediWound FDA EventsPhio Pharmaceuticals FDA EventsRadiopharm Theranostics FDA EventsTenaya Therapeutics FDA EventsJohnson & Johnson 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 Inspire Medical Systems 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. We continuously monitor for new FDA events and market data. From Our PartnersThe only 5 stocks that matterSpaceX's IPO reportedly minted 4,400 new millionaires, and OpenAI is said to be eyeing a 1 trillion dollar IPO...TradeSmith | SponsoredWhy I went to Mount RushmoreA small miner just hit on gold in the hills surrounding Mount Rushmore, thanks to a breakthrough new technolog...Stansberry Research | SponsoredHow options let you do more with less capitalWould you rather spend $5,000 buying 100 shares of a $50 stock, or control those same 100 shares for a fractio...Base Camp Trading | SponsoredBlackRock and Vanguard already own THISInstitutions own roughly 88 percent of an overlooked American oil and natural gas company. BlackRock holds 32 ...Monument Traders Alliance | SponsoredWhy the Treasury still prices gold at 42 dollars an ounceThe U.S. Treasury still values its gold reserves at 42.22 dollars an ounce, a price set in 1973. Gold trades n...Golden Portfolio | SponsoredGold just passed our debt as the world's #1 assetChina's US Treasury holdings have fallen from a peak of $1.32 trillion to roughly $659 billion, an 18-year low...Behind the Markets | SponsoredPrint this before your next tradeBill Poulos is offering his Smart Trade Options Checklist at no cost today - normally priced at $29.97. It'...Profits Run | SponsoredElon Musk to Trigger Next AI Wave on November 11th?Jeff Brown picked Nvidia in 2016, before shares surged 37,800 percent. Now he's identified another AI company ...Brownstone Research | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding QuidelOrtho Corporation Please log in to your account or sign up in order to add this asset to your watchlist. Share QuidelOrtho With A Colleague Link copied to clipboard. Unlock superior investment research and tools. Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools and reports. Get MarketBeat All Access MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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
Free QDEL Stock Alerts