QuidelOrtho's Drug in the FDA Approval Process
This 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.
- Drug:
- ORTHO VISION
- Announced Date:
- October 16, 2025
- Indication:
- for patients who depend on timely transfusion decisions.
Announcement
QuidelOrtho Corporation will highlight its ongoing commitment to transfusion medicine excellence at the Association for the Advancement of Blood & Biotherapies (AABB) 2025 Annual Meeting.
AI Summary
QuidelOrtho 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
As of now, QuidelOrtho (QDEL) has not received any FDA approvals for its therapy in the last two years.
In the past two years, QuidelOrtho (QDEL) has reported FDA regulatory activity for ORTHO VISION.
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."
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 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
This page (NASDAQ:QDEL) was last updated on 10/22/2025 by MarketBeat.com Staff
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