Hologic (HOLX) FDA Approvals

Hologic's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Hologic (HOLX). Over the past two years, Hologic has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Panther. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. FDA Regulatory Events

Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. is a drug developed by Hologic for the following indication: Detect Common Causes of Infectious Gastroenteritis. 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.

FDA Clearance - October 2,2025

• Drug: Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays.
• Announced Date: October 2, 2025
• Indication: Detect Common Causes of Infectious Gastroenteritis

Hologic, Inc announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays.

Hologic, Inc. announced that the U.S. Food and Drug Administration has granted 510(k) clearance for its Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. These new molecular tests are designed to quickly detect the most common bacterial causes of infectious gastroenteritis, such as Salmonella, Campylobacter, Shigella, E. coli (including O157), Vibrio, Yersinia and Plesiomonas.

The assays can be run together or in any combination, letting laboratories tailor testing panels to each patient’s needs. This mini-panel approach helps reduce unnecessary tests, streamlines workflows and speeds up time to diagnosis.

By providing fast, accurate results, the assays support informed clinical decisions and antimicrobial stewardship, ensuring antibiotics are used only when needed. Testing is performed on Hologic’s fully automated Panther Fusion System, which integrates easily into existing lab operations.

This clearance highlights Hologic’s commitment to advancing diagnostic innovation and raising the standard of care for patients with suspected bacterial GI infections.

Hologic FDA Events - Frequently Asked Questions

Has Hologic received FDA approval?

As of now, Hologic (HOLX) has not received any FDA approvals for its therapy in the last two years.

What drugs has Hologic submitted to the FDA?

In the past two years, Hologic (HOLX) has reported FDA regulatory activity for Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays..

What is the most recent FDA event for Hologic?

The most recent FDA-related event for Hologic occurred on October 2, 2025, involving Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays.. The update was categorized as "FDA Clearance," with the company reporting: "Hologic, Inc announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays."

What conditions do Hologic's current drugs treat?

Currently, Hologic has one therapy (Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays.) targeting the following condition: Detect Common Causes of Infectious Gastroenteritis.