Guardant Health Fda Approved

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Guardant Health, Inc. - Guardant Health Receives FDA Approval for

(3 days ago) WebBlood test provides simple way to test patients comprehensively for tumor alterations that drive selection of targeted therapies, now including ENHERTU Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that …

https://investors.guardanthealth.com/press-releases/press-releases/2022/Guardant-Health-Receives-FDA-Approval-for-Guardant360-CDx-as-Companion-Diagnostic-for-Daiichi-Sankyo-and-AstraZenecas-ENHERTU-for-Treatment-of-NSCLC-Patients-With-Activating-HER2-Mutations/default.aspx

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Guardant Health, Inc. - Guardant Health receives FDA approval for

(9 days ago) WebThe approval as a companion diagnostic for ORSERDU is Guardant Health’s fifth FDA approval for the Guardant360 CDx test and its first in breast cancer. …

https://investors.guardanthealth.com/press-releases/press-releases/2023/Guardant-Health-receives-FDA-approval-for-Guardant360-CDx-as-companion-diagnostic-for-Menarini-Groups-ORSERDU-for-treatment-of-patients-with-ESR1-mutations-in-ER-HER2--advanced-or-metastatic-breast-cancer/default.aspx

Category: Cancer Show Health

FDA Advisory Panel Review of Guardant Health’s Shield™ Blood …

(Just Now) WebPALO ALTO, Calif., April 22, 2024--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the Molecular and Clinical Genetics …

https://finance.yahoo.com/news/fda-advisory-panel-review-guardant-125200837.html

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FDA approves Guardant's tumor-sequencing blood test …

(8 days ago) WebGuardant Health received a milestone approval from the FDA for its cancer test, as the first liquid biopsy able to genetically profile solid tumors anywhere in the body through a single blood draw.

https://www.fiercebiotech.com/medtech/fda-approves-guardant-s-next-gen-tumor-sequencing-blood-test

Category: Cancer Show Health

Guardant Health CDx Wins FDA Approval for First Liquid Biopsy …

(7 days ago) WebNEW YORK – Guardant Health said Friday that the US Food and Drug Administration has approved its targeted next-generation sequencing liquid biopsy …

https://www.precisionmedicineonline.com/liquid-biopsy/guardant-health-cdx-wins-fda-approval-first-liquid-biopsy-ngs-tumor-profiling-assay

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Guardant360 CDx – P200010/S008 FDA

(9 days ago) WebGuardant360 CDx is a laboratory test for gene mutations in cfDNA. This approval is for detecting ERBB2 activating mutations (SNV and exon 20 insertions).

https://www.fda.gov/medical-devices/recently-approved-devices/guardant360-cdx-p200010s008

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Guardant360® CDx: Fastest FDA-Approved Liquid CGP Panel

(8 days ago) WebGuardant360 tests are covered across 300 million lives with all major insurers, including Aetna, Anthem, Cigna, United Healthcare, and others. *Based on Guardant Health data …

https://www.guardantcomplete.com/products/guardant360-cdx/

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Guardant360® CDx Receives FDA Approval as First and Only …

(7 days ago) WebREDWOOD CITY, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH) announces that the U.S. Food and Drug Administration (FDA) has …

https://www.businesswire.com/news/home/20210528005396/en/Guardant360%C2%AE-CDx-Receives-FDA-Approval-as-First-and-Only-Liquid-Biopsy-Companion-Diagnostic-for-Amgen%E2%80%99s-LUMAKRAS%E2%84%A2-sotorasib-KRASG12C-Inhibitor-for-Use-in-Advanced-Non-Small-Cell-Lung-Cancer

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Guardant Health Receives FDA Approval for Guardant360

(6 days ago) WebGuardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that the U.S. Food and Drug Administration (FDA) has approve

https://www.businesswire.com/news/home/20220811005816/en/Guardant-Health-Receives-FDA-Approval-for-Guardant360%C2%AE-CDx-as-Companion-Diagnostic-for-Daiichi-Sankyo-and-AstraZeneca%E2%80%99s-ENHERTU%C2%AE-for-Treatment-of-NSCLC-Patients-With-Activating-HER2-Mutations

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Guardant Health, Inc. - Food and Drug Administration

(3 days ago) WebGuardant Health, Inc. May 21, 2021. Katie Bessette, Ph.D., RAC Senior Director, Regulatory Affairs 505 Penobscot Drive Redwood City, CA 94063 Be advised that …

https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200010S001A.pdf

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Guardant Health Announces Tentative Date of FDA Advisory Panel …

(6 days ago) WebPALO ALTO, Calif., December 19, 2023--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug …

https://finance.yahoo.com/news/guardant-health-announces-tentative-date-210500885.html

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Guardant360 CDx – P200010/S002 FDA

(9 days ago) WebPMA Applicant: Guardant Health, Inc. Address: 505 Penobscot Drive Redwood City, CA 94063 USA Approval Date: (NSCLC) who may benefit from …

https://www.fda.gov/medical-devices/recently-approved-devices/guardant360-cdx-p200010s002

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FDA Advisory Panel Review of Guardant Health’s Shield - BioSpace

(Just Now) WebPALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the Molecular and Clinical …

https://www.biospace.com/article/releases/fda-advisory-panel-review-of-guardant-health-s-shield-blood-test-to-screen-for-colorectal-cancer-to-be-held-on-may-23/

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Knoxville residents can try a new blood test to screen for cancer

(7 days ago) WebThe test, called Shield, is a product of Guardant Health in Silicon Valley. Shield has not yet been approved by the FDA and is not covered by insurance. It currently costs $895 out …

https://www.msn.com/en-us/health/other/knoxville-residents-can-try-a-new-blood-test-to-screen-for-cancer-before-a-colonoscopy/ar-BB1lfTmB

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FDA to review Guardant Health's cancer screening test

(4 days ago) WebThe review by the FDA Advisory Committee represents a critical step for Guardant Health in potentially bringing the Shield blood test to market, pending …

https://www.investing.com/news/company-news/fda-to-review-guardant-healths-cancer-screening-test-3388823

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Guardant Health, Inc. - Guardant360® CDx Receives FDA Approval …

(5 days ago) WebGuardant Health blood test identifies patients with EGFR exon 20 insertion mutations who may benefit from targeted treatment with RYBREVANT™ after …

https://investors.guardanthealth.com/press-releases/press-releases/2021/Guardant360-CDx-Receives-FDA-Approval-as-Companion-Diagnostic-for-Janssens-RYBREVANT-amivantamab-vmjw-for-Use-in-Patients-with-Advanced-Non-Small-Cell-Lung-Cancer-with-EGFR-Exon-20-Insertion-Mutations/default.aspx

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Guardant360 CDx - P200010/S010 FDA

(9 days ago) WebGuardant360 CDx is a laboratory test designed to detect gene mutations found in circulating cell-free DNA (cfDNA). This test helps doctors identify people with …

https://www.fda.gov/medical-devices/recently-approved-devices/guardant360-cdx-p200010s010

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US FDA sends warning letter to Cardinal Health for marketing …

(7 days ago) WebThe U.S. health regulator has sent a warning letter to Cardinal Health after an inspection of its facility in Illinois found the company was marketing and distributing …

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-sends-warning-cardinal-health-marketing-unapproved-devices-2024-04-25/

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and …

(Just Now) Webmake recommendations, and vote on information regarding the premarket approval application for the Shield test by Guardant Health, Inc. The proposed indication for use …

https://public-inspection.federalregister.gov/2024-08656.pdf

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