Revvity's Drug in the FDA Approval Process
This 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.
- Drug:
- T1D 4-plex
- Announced Date:
- October 2, 2025
- Indication:
- diabetic ketoacidosis (DKA)
Announcement
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.
AI Summary
Revvity, 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
As of now, Revvity (RVTY) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Revvity (RVTY) has reported FDA regulatory activity for T1D 4-plex.
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."
Currently, Revvity has one therapy (T1D 4-plex) targeting the following condition: diabetic ketoacidosis (DKA).
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 (NYSE:RVTY) was last updated on 10/3/2025 by MarketBeat.com Staff
