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Home Industry News & Regulatory Approvals

FDA Perspectives on the Use of Liquid Biopsy in NSCLC

Kara Nyberg, PhD
on: October 09, 2020In: Industry News & Regulatory Approvals, Meeting News
FDA Perspectives on the Use of Liquid Biopsy in NSCLC

The US Food and Drug Administration (FDA) recognizes the value of liquid biopsy in managing patients with cancer, and the agency is actively working to bring these assays to the clinic. Harpreet Singh, MD, Director of […] Read more


Funding Opportunities for Innovative Multidisciplinary Cancer Research Teams

on: October 05, 2020In: Industry News & Regulatory Approvals
Funding Opportunities for Innovative Multidisciplinary Cancer Research Teams

The US National Cancer Institute (NCI), a division of the US National institutes of Health (NIH), is partnering with Cancer Research UK, the world’s largest independent cancer research charity, to […] Read more

FDA Approves Pralsetinib for RET Fusion–Positive NSCLC

on: October 01, 2020In: Industry News & Regulatory Approvals
FDA Approves Pralsetinib for RET Fusion–Positive NSCLC

The US Food and Drug Administration (FDA) granted Accelerated Approval to pralsetinib as treatment for adults with metastatic NSCLC who harbor RET fusions. The first and only test to identify RET fusion–positive NSCLC, the Oncomine Dx Target […] Read more

Huge Strides for Liquid Biopsy Assays with Two FDA Approvals

on: October 01, 2020In: Industry News & Regulatory Approvals
Huge Strides for Liquid Biopsy Assays with Two FDA Approvals

August 2020 was a groundbreaking month for liquid biopsy technology, with two assays approved by the US Food and Drug Administration (FDA) as companion diagnostics just weeks apart. The Guardant360 CDx assay, approved August 7, was […] Read more

Dr. Harpreet Singh Discusses the Conduct of FDA Clinical Trials During the COVID-19 Pandemic

Harpreet Singh, MD
on: September 29, 2020In: Evolving Standards of Care, Industry News & Regulatory Approvals
Dr. Harpreet Singh Discusses the Conduct of FDA Clinical Trials During the COVID-19 Pandemic

Harpreet Singh, MD, is director of Division of Oncology 2 at the U.S. Food and Drug Administration (FDA). In the following interview, she discusses the FDA’s response to the COVID-19 […] Read more

Changing E-Cigarette Technology Leads to Increased Complexity and Confusion—IASLC Statement Aims for Clarity

on: November 11, 2019In: Industry News & Regulatory Approvals
Changing E-Cigarette Technology Leads to Increased Complexity and Confusion—IASLC Statement Aims
            for Clarity

Posted: November 12, 2019 Dr. Matthew Steliga, chair of the IASLC Tobacco Control and Smoking Cessation Committee and thoracic surgeon and head of the Tobacco Cessation Program at Winthrop P. […] Read more

Breaking News Briefs

on: May 31, 2018In: Industry News & Regulatory Approvals
Breaking News Briefs

New Lung Cancer Screening Guidelines Will Save Lives Reaction was swift and positive last week to new draft guidelines from the U.S. Preventive Services Task Force lowering the requirements for […] Read more

Breaking News Briefs

on: May 31, 2018In: Industry News & Regulatory Approvals
Breaking News Briefs

Nivolumab in the News The dosing schedule for nivolumab now includes a flat dose of 480 mg infused every 4 weeks (Q4W) for a majority of approved indications, including patients […] Read more

Breaking News Briefs

on: April 05, 2018In: Industry News & Regulatory Approvals
Breaking News Briefs

Tumors with high TMB responded well to combination in large patient population. By now the results of the phase III CheckMate-227 study are known by most. The primary endpoint of […] Read more

Breaking News Briefs

on: February 19, 2018In: Industry News & Regulatory Approvals
Breaking News Briefs

The FoundationOne CDx (F1CDx) test received full U.S. Food and Drug Administration (FDA) approval. F1CDx is the first breakthrough-designated, next-generation sequencing–based in vitro diagnostic (IVD) test to detect genetic mutations […] Read more

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