FDA Events for Becton, Dickinson and Company (BDX)
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
GalaFLEX. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
GalaFLEX LITE - FDA Regulatory Timeline and 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.
- Drug:
- GalaFLEX LITE
- Announced Date:
- March 20, 2025
- Indication:
- In Breast Implant Revision Surgery
Announcement
BD (Becton, Dickinson and Company) announced the first patient treated in an Investigational Device Exemption (IDE) clinical trial intended to advance BD's efforts to achieve Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the use of GalaFLEX LITE™ Scaffold in decreasing capsular contracture (CC) recurrence during breast revision surgery.
AI Summary
BD (Becton, Dickinson and Company) announced a major milestone in its quest for FDA Premarket Approval for its innovative use of the GalaFLEX LITE™ Scaffold. The company treated the first patient in an Investigational Device Exemption clinical trial designed to reduce the recurrence of capsular contracture—an often painful and displacing complication—after breast revision surgery. Capsular contracture, where scar tissue hardens around an implant, poses significant challenges and the trial aims to show how the absorbable GalaFLEX LITE™ Scaffold, made from Poly-4-Hydroxybutyrate (P4HB), can improve outcomes by providing strength and stability during healing. This early achievement marks an important step forward in clinical research, highlighting BD’s commitment to advancing biomaterial science and working closely with the FDA to offer safer, more effective options for patients undergoing breast revision procedures.
Read Announcement
Becton, Dickinson and Company FDA Events - Frequently Asked Questions
As of now, Becton, Dickinson and Company (BDX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Becton, Dickinson and Company (BDX) has reported FDA regulatory activity for GalaFLEX LITE.
The most recent FDA-related event for Becton, Dickinson and Company occurred on March 20, 2025, involving GalaFLEX LITE. The update was categorized as "Provided Update," with the company reporting: "BD (Becton, Dickinson and Company) announced the first patient treated in an Investigational Device Exemption (IDE) clinical trial intended to advance BD's efforts to achieve Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the use of GalaFLEX LITE™ Scaffold in decreasing capsular contracture (CC) recurrence during breast revision surgery."
Currently, Becton, Dickinson and Company has one therapy (GalaFLEX LITE) targeting the following condition: In Breast Implant Revision Surgery.
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:BDX) was last updated on 7/13/2025 by MarketBeat.com Staff
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