Industry News & Regulatory Approvals
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In Brief for Feb. 8, 2023
Dr. Carolyn Dresler Joins Action on Smoking and Health (ASH) Board of Trustees; Novel Liquid Biopsy Assay for Lung Carcinoma Detection Receives FDA Breakthrough Device Designation.
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In Brief for January 25, 2023
China approves mobocertinib for patients with EGFR Exon20 insertion+ NSCLC; Deadline approaching for IASLC 2023 Lectureship and Distinguished Service Award Nominations.
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In Brief for Jan. 11, 2023
Japan greenlights durvalumab and tremelimumab in combination with chemotherapy; US approves companion diagnostic tool for certain TKIs and expands indications for pemetrexed injection.
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Regulatory News for Nov. 23, 2022
US Food and Drug Administration approves two combinations for non-small cell lung cancer.
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Real-World Data from Taiwan Shows Stage Shift Has Improved Lung Cancer Survival Rates
Researchers say increased screening of at-risk populations, including those who have never smoked, may improve survival more than any other strategy.
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US FDA’s Review of Single-Country ‘Me Too’ Drugs: A Clinical Trialist Perspective
With no direct comparison to the standard of care and limited resources to review applications, researchers say they support the agency’s decision not to approve sintilimab.
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In Brief for May 25, 2022
5th edition of patient education book released; US FDA moves to prohibit tobacco flavoring.
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In Brief for May 11, 2022
Winship Cancer Institute announces preceptor opportunity. NICE recommends tepotinib for select patients.
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The FDA Explained: An Interview with Dr. Harpreet Singh
During an episode of IASLC’s Lung Cancer Considered podcast, Dr. Singh provided insight into the US agency’s approval process. Here are some highlights.
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US FDA greenlights nivolumab for use before surgery for NSCLC
Approval opens the door for an immunotherapy-based treatment option prior to surgery for the first time.
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