Revvity (RVTY) FDA Approvals

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.

Provided Update - October 2,2025

• Drug: T1D 4-plex
• Announced Date: October 2, 2025
• Indication: diabetic ketoacidosis (DKA)
• Other Companies Involved: NASDAQ:SNY

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.

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.

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).