Align Technology (ALGN) FDA Approvals $174.84 -1.67 (-0.95%) Closing price 04:00 PM EasternExtended Trading$174.98 +0.14 (+0.08%) As of 07:45 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 EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Align Technology's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Align Technology (ALGN). Over the past two years, Align Technology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Invisalign. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Invisalign Smile Architect™ FDA Regulatory Events Invisalign Smile Architect™ is a drug developed by Align Technology for the following indication: Multiple Treatment Plans allowing doctors to visually compare and modify orthodontic only and ortho restorative treatment plans side-by-side. 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 - May 21,2026Highlights Drug: Invisalign Smile Architect™Announced Date: May 21, 2026Indication: Multiple Treatment Plans allowing doctors to visually compare and modify orthodontic only and ortho restorative treatment plans side-by-side.AnnouncementAlign Technology, Inc today shared highlights of its 2026 Invisalign® EMEA Ortho Summit, which brought together approximately 400 orthodontists and dental professionals from across Europe, the Middle East, and Africa (EMEA).AI SummaryAlign Technology said its 2026 Invisalign EMEA Ortho Summit brought together about 400 orthodontists and dental professionals in Barcelona, Spain. The three-day event focused on the company’s next-generation digital tools for treating complex cases in kids, teens, and adults, including Class II malocclusions. Attendees got a hands-on look at the Align Innovation Hub, which showed a full digital patient journey from consultation to treatment and retention. The summit also featured doctor-led sessions on difficult cases, digital workflow improvement, and patient engagement. Align said the event highlighted how its digital platform can connect scanning, treatment planning, appliance production, monitoring, and retention into one system. The company said these tools are meant to improve treatment precision, save time for practices, and make care easier for patients.Read Announcement Align Technology FDA Events - Frequently Asked Questions Has Align Technology received FDA approval? As of now, Align Technology (ALGN) has not received any FDA approvals for its therapy in the last two years. What drugs has Align Technology submitted to the FDA? In the past two years, Align Technology (ALGN) has reported FDA regulatory activity for Invisalign Smile Architect™. What is the most recent FDA event for Align Technology? The most recent FDA-related event for Align Technology occurred on May 21, 2026, involving Invisalign Smile Architect™. The update was categorized as "Highlights," with the company reporting: "Align Technology, Inc today shared highlights of its 2026 Invisalign® EMEA Ortho Summit, which brought together approximately 400 orthodontists and dental professionals from across Europe, the Middle East, and Africa (EMEA)." What conditions do Align Technology's current drugs treat? Currently, Align Technology has one therapy (Invisalign Smile Architect™) targeting the following condition: Multiple Treatment Plans allowing doctors to visually compare and modify orthodontic only and ortho restorative treatment plans side-by-side.. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events BioCryst Pharmaceuticals FDA EventsCogent Biosciences FDA EventsJazz Pharmaceuticals FDA EventsKymera Therapeutics FDA EventsAbbVie FDA EventsAC Immune FDA EventsAscendis Pharma A/S FDA EventsC4 Therapeutics FDA EventsCompugen FDA EventsCellectis FDA EventsClimb Bio FDA EventsCaribou Biosciences FDA EventsAlpha Tau Medical FDA EventsGuardant Health FDA EventsGenmab A/S 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 DexCom FDA Events Quanterix FDA Events Cardinal Health FDA Events Haemonetics FDA Events Merit Medical Systems FDA Events QuidelOrtho FDA Events Cerus FDA Events Anika Therapeutics FDA Events Becton, Dickinson and Company FDA Events Alnylam Pharmaceuticals FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:ALGN last updated on 5/22/2026 by MarketBeat.com Staff. 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Highlights - May 21,2026Highlights Drug: Invisalign Smile Architect™Announced Date: May 21, 2026Indication: Multiple Treatment Plans allowing doctors to visually compare and modify orthodontic only and ortho restorative treatment plans side-by-side.AnnouncementAlign Technology, Inc today shared highlights of its 2026 Invisalign® EMEA Ortho Summit, which brought together approximately 400 orthodontists and dental professionals from across Europe, the Middle East, and Africa (EMEA).AI SummaryAlign Technology said its 2026 Invisalign EMEA Ortho Summit brought together about 400 orthodontists and dental professionals in Barcelona, Spain. The three-day event focused on the company’s next-generation digital tools for treating complex cases in kids, teens, and adults, including Class II malocclusions. Attendees got a hands-on look at the Align Innovation Hub, which showed a full digital patient journey from consultation to treatment and retention. The summit also featured doctor-led sessions on difficult cases, digital workflow improvement, and patient engagement. Align said the event highlighted how its digital platform can connect scanning, treatment planning, appliance production, monitoring, and retention into one system. The company said these tools are meant to improve treatment precision, save time for practices, and make care easier for patients.Read Announcement
