Revvity (RVTY) FDA Approvals $151.46 +2.40 (+1.61%) Closing price 03:59 PM EasternExtended Trading$151.48 +0.01 (+0.01%) As of 05:29 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 ForecastsChartCompetitorsDividendEarningsFDA EventsFinancialsInsider TradesNews and TrendsOptions ChainOwnershipSEC FilingsShort Interest Revvity's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Revvity (RVTY). Over the past two years, Revvity has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as T1D. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. T1D 4-plex FDA Regulatory Events T1D 4-plex is a drug developed by Revvity for the following indication: diabetic ketoacidosis (DKA). 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. Provided Update - October 2,2025Provided Update Drug: T1D 4-plexAnnounced Date: October 2, 2025Indication: diabetic ketoacidosis (DKA)Other Companies Involved: NASDAQ:SNY AnnouncementRevvity, Inc. announced a program for expansion of its type 1 diabetes (T1D) offering to include a population-scale assay for early detection with support from Revvity will develop a T1D 4-plex in vitro diagnostic (IVD) assay based on its existing research-use (RUO) 3-plex assay.AI SummaryRevvity, Inc. and Sanofi have launched a program to expand testing for type 1 diabetes (T1D) by creating a new population‐scale assay for early detection. Building on Revvity’s research‐use 3-plex assay, the companies will develop a T1D 4-plex in vitro diagnostic (IVD) test. This assay will run on Revvity’s high‐throughput GSP® instrument and use both capillary dried blood spots and standard blood draws. By spotting autoimmune markers earlier, doctors can intervene sooner to slow disease progression and reduce the risk of serious complications like diabetic ketoacidosis. The collaboration will support clinical validation and regulatory filings, including submissions to the U.S. FDA and European IVDR authorities. In parallel, Revvity Omics will expand its existing lab-developed T1D test beyond its Pittsburgh facility, making the assay available at multiple global labs for broader patient access.Read Announcement Revvity FDA Events - Frequently Asked Questions Has Revvity received FDA approval? As of now, Revvity (RVTY) has not received any FDA approvals for its therapy in the last two years. What drugs has Revvity submitted to the FDA? In the past two years, Revvity (RVTY) has reported FDA regulatory activity for T1D 4-plex. What is the most recent FDA event for Revvity? The most recent FDA-related event for Revvity occurred on October 2, 2025, involving T1D 4-plex. The update was categorized as "Provided Update," with the company reporting: "Revvity, Inc. announced a program for expansion of its type 1 diabetes (T1D) offering to include a population-scale assay for early detection with support from Revvity will develop a T1D 4-plex in vitro diagnostic (IVD) assay based on its existing research-use (RUO) 3-plex assay." What conditions do Revvity's current drugs treat? Currently, Revvity has one therapy (T1D 4-plex) targeting the following condition: diabetic ketoacidosis (DKA). More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Agenus FDA EventsInflaRx FDA EventsCentury Therapeutics FDA EventsObsidian Therapeutics FDA EventsSurrozen FDA EventsVera Therapeutics FDA EventsVerastem FDA EventsJohnson & Johnson FDA EventsTeva Pharmaceutical Industries FDA EventsAktis Oncology FDA EventsAgomAb Therapeutics FDA EventsArtiva Biotherapeutics FDA EventsArvinas FDA EventsBioCardia FDA EventsCandel 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 Agilent Technologies FDA Events Qiagen FDA Events Adaptive Biotechnologies FDA Events Personalis FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NYSE:RVTY last updated on 10/2/2025 by MarketBeat.com Staff. 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Provided Update - October 2,2025Provided Update Drug: T1D 4-plexAnnounced Date: October 2, 2025Indication: diabetic ketoacidosis (DKA)Other Companies Involved: NASDAQ:SNY AnnouncementRevvity, Inc. announced a program for expansion of its type 1 diabetes (T1D) offering to include a population-scale assay for early detection with support from Revvity will develop a T1D 4-plex in vitro diagnostic (IVD) assay based on its existing research-use (RUO) 3-plex assay.AI SummaryRevvity, Inc. and Sanofi have launched a program to expand testing for type 1 diabetes (T1D) by creating a new population‐scale assay for early detection. Building on Revvity’s research‐use 3-plex assay, the companies will develop a T1D 4-plex in vitro diagnostic (IVD) test. This assay will run on Revvity’s high‐throughput GSP® instrument and use both capillary dried blood spots and standard blood draws. By spotting autoimmune markers earlier, doctors can intervene sooner to slow disease progression and reduce the risk of serious complications like diabetic ketoacidosis. The collaboration will support clinical validation and regulatory filings, including submissions to the U.S. FDA and European IVDR authorities. In parallel, Revvity Omics will expand its existing lab-developed T1D test beyond its Pittsburgh facility, making the assay available at multiple global labs for broader patient access.Read Announcement
