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Edwards Lifesciences (EW) FDA Events

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FDA Events for Edwards Lifesciences (EW)

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

Edwards Lifesciences' Drugs in FDA Review

PROACTIVE-HF - FDA Regulatory Timeline and Events

PROACTIVE-HF is a drug developed by Edwards Lifesciences for the following indication: For the Cordella Pulmonary Artery (PA) Sensor 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.

SAPIEN - FDA Regulatory Timeline and Events

SAPIEN is a drug developed by Edwards Lifesciences for the following indication: For Ultra transcatheter heart valve. 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.

Edwards Lifesciences FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Edwards Lifesciences (EW) has reported FDA regulatory activity for the following drugs: SAPIEN and PROACTIVE-HF.

The most recent FDA-related event for Edwards Lifesciences occurred on May 1, 2025, involving SAPIEN. The update was categorized as "FDA approved," with the company reporting: "Edwards Lifesciences announced today that the U.S. Food and Drug Administration (FDA) has approved its transcatheter aortic valve replacement (TAVR) therapy, the SAPIEN 3 platform, for severe aortic stenosis (AS) patients without symptoms, marking the first FDA approval for TAVR in asymptomatic patients."

Current therapies from Edwards Lifesciences in review with the FDA target conditions such as:

  • For Ultra transcatheter heart valve - SAPIEN
  • For the Cordella Pulmonary Artery (PA) Sensor System. - PROACTIVE-HF

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