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GE HealthCare Technologies (GEHC) FDA Events

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FDA Events for GE HealthCare Technologies (GEHC)

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

GE HealthCare Technologies' Drugs in FDA Review

Cerianna - FDA Regulatory Timeline and Events

Cerianna is a drug developed by GE HealthCare Technologies for the following indication: For Lobular Breast Cancer. 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.

Flyrcado - FDA Regulatory Timeline and Events

Flyrcado is a drug developed by GE HealthCare Technologies for the following indication: for enhanced diagnosis of coronary artery disease. 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.

macrocyclic magnetic resonance imaging - FDA Regulatory Timeline and Events

macrocyclic magnetic resonance imaging is a drug developed by GE HealthCare Technologies for the following indication: MRI Contrast Agent. 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.

Vizamyl - FDA Regulatory Timeline and Events

Vizamyl is a drug developed by GE HealthCare Technologies for the following indication: For beta-amyloid detection. 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.

GE HealthCare Technologies FDA Events - Frequently Asked Questions

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

In the past two years, GE HealthCare Technologies (GEHC) has reported FDA regulatory activity for the following drugs: Vizamyl, Cerianna, macrocyclic magnetic resonance imaging and Flyrcado.

The most recent FDA-related event for GE HealthCare Technologies occurred on June 24, 2025, involving Vizamyl. The update was categorized as "FDA Approval," with the company reporting: "GE HealthCare announced that the U.S. Food and Drug Administration (FDA) has approved an updated label for its positron emission tomography (PET) imaging agent VizamylTM (flutemetamol F 18 injection) for beta-amyloid detection."

Current therapies from GE HealthCare Technologies in review with the FDA target conditions such as:

  • For beta-amyloid detection. - Vizamyl
  • For Lobular Breast Cancer - Cerianna
  • MRI Contrast Agent - macrocyclic magnetic resonance imaging
  • for enhanced diagnosis of coronary artery disease - Flyrcado

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 (NASDAQ:GEHC) was last updated on 7/10/2025 by MarketBeat.com Staff
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