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Becton, Dickinson and Company (BDX) FDA Approvals

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Becton, Dickinson and Company's Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Becton, Dickinson and Company (BDX). Over the past two years, Becton, Dickinson and Company has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as BD and GalaFLEX. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

BD Veritor™ System FDA Regulatory Events

BD Veritor™ System is a drug developed by Becton, Dickinson and Company for the following indication: For SARS-CoV-2. 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.

GalaFLEX LITE FDA Regulatory Events

GalaFLEX LITE is a drug developed by Becton, Dickinson and Company for the following indication: In Breast Implant Revision Surgery. 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.

Becton, Dickinson and Company FDA Events - Frequently Asked Questions

In the past two years, Becton, Dickinson and Company (BDX) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, Becton, Dickinson and Company (BDX) has reported FDA regulatory activity for the following drugs: BD Veritor™ System and GalaFLEX LITE.

The most recent FDA-related event for Becton, Dickinson and Company occurred on July 30, 2025, involving BD Veritor™ System. The update was categorized as "FDA Clearance," with the company reporting: "BD (Becton, Dickinson and Company) announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Veritor™ System for SARS-CoV-2, a digital test designed to detect COVID-19 antigens in symptomatic individuals in about 15 minutes at doctors' offices, urgent care centers, retail clinics and other convenient points of care."

Current therapies from Becton, Dickinson and Company in review with the FDA target conditions such as:

  • For SARS-CoV-2 - BD Veritor™ System
  • In Breast Implant Revision Surgery - GalaFLEX LITE

More FDA Event Resources from MarketBeat

  • 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:BDX) was last updated on 8/2/2025 by MarketBeat.com Staff
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