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Abbott Laboratories (ABT) FDA Events

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FDA Events for Abbott Laboratories (ABT)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Abbott Laboratories (ABT). Over the past two years, Abbott Laboratories has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Deep, Esprit, Libre, Lingo, and Tendyne™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Abbott Laboratories' Drugs in FDA Review

Deep brain stimulation (DBS) system - FDA Regulatory Timeline and Events

Deep brain stimulation (DBS) system is a drug developed by Abbott Laboratories for the following indication: Treatment-resistant depression (TRD), a form of major depressive disorder (MDD). 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.

Esprit BTK System - FDA Regulatory Timeline and Events

Esprit BTK System is a drug developed by Abbott Laboratories for the following indication: for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK). This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Libre Rio - FDA Regulatory Timeline and Events

Libre Rio is a drug developed by Abbott Laboratories for the following indication: for people with diabetes. 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.

Lingo - FDA Regulatory Timeline and Events

Lingo is a drug developed by Abbott Laboratories for the following indication: to improve their overall health and wellness. 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.

Tendyne™ - FDA Regulatory Timeline and Events

Tendyne™ is a drug developed by Abbott Laboratories for the following indication: Transcatheter mitral valve replacement (TMVR) system. 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.

Abbott Laboratories FDA Events - Frequently Asked Questions

Yes, Abbott Laboratories (ABT) has received FDA approval for Esprit BTK System. This page tracks recent and historical FDA regulatory events related to Abbott Laboratories' drug portfolio.

In the past two years, Abbott Laboratories (ABT) has reported FDA regulatory activity for the following drugs: Tendyne™, Deep brain stimulation (DBS) system, Lingo, Libre Rio and Esprit BTK System.

The most recent FDA-related event for Abbott Laboratories occurred on May 27, 2025, involving Tendyne™. The update was categorized as "FDA approved," with the company reporting: "Abbott announced the U.S. Food and Drug Administration (FDA) has approved the company's Tendyne™ transcatheter mitral valve replacement (TMVR) system to treat people with mitral valve disease."

Current therapies from Abbott Laboratories in review with the FDA target conditions such as:

  • Transcatheter mitral valve replacement (TMVR) system - Tendyne™
  • Treatment-resistant depression (TRD), a form of major depressive disorder (MDD) - Deep brain stimulation (DBS) system
  • to improve their overall health and wellness. - Lingo
  • for people with diabetes - Libre Rio
  • for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK). - Esprit BTK System

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:ABT) was last updated on 7/10/2025 by MarketBeat.com Staff
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