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Guardant Health (GH) FDA Events

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FDA Events for Guardant Health (GH)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Guardant Health (GH). Over the past two years, Guardant Health has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Guardant360, RYBREVANT, and Shield™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Guardant Health's Drugs in FDA Review

Guardant360 - FDA Regulatory Timeline and Events

Guardant360 is a drug developed by Guardant Health for the following indication: Advanced solid tumors. 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.

RYBREVANT (amivantamab-vmjw) - FDA Regulatory Timeline and Events

RYBREVANT (amivantamab-vmjw) is a drug developed by Guardant Health for the following indication: Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Shield™ blood test - FDA Regulatory Timeline and Events

Shield™ blood test is a drug developed by Guardant Health for the following indication: for colorectal cancer (CRC) screening. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Guardant Health FDA Events - Frequently Asked Questions

Yes, Guardant Health (GH) has received FDA approval for multiple therapies, including RYBREVANT (amivantamab-vmjw) and Shield™ blood test. This page tracks recent and historical FDA regulatory events related to Guardant Health's drug portfolio.

In the past two years, Guardant Health (GH) has reported FDA regulatory activity for the following drugs: RYBREVANT (amivantamab-vmjw), Guardant360 and Shield™ blood test.

The most recent FDA-related event for Guardant Health occurred on June 2, 2025, involving Guardant360. The update was categorized as "Results," with the company reporting: "Guardant Health, Inc announced that the results of the Phase III SERENA-6 trial - sponsored by AstraZeneca - demonstrate the clinical value of the Guardant360® CDx test in a circulating tumor DNA-guided approach to detect and treat emerging resistance in 1st-line therapy ahead of radiological disease progression in breast cancer."

Current therapies from Guardant Health in review with the FDA target conditions such as:

  • Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations - RYBREVANT (amivantamab-vmjw)
  • Advanced solid tumors. - Guardant360
  • for colorectal cancer (CRC) screening - Shield™ blood test

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