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Home Industry News & Regulatory Approvals

In Brief for Jan. 11, 2023

John Austin
on: January 10, 2023In: Industry News & Regulatory Approvals
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. Read more


Regulatory News for Nov. 23, 2022

Erin Jungmeyer
on: November 22, 2022In: Industry News & Regulatory Approvals
Regulatory News for Nov. 23, 2022

US Food and Drug Administration approves two combinations for non-small cell lung cancer. Read more

Real-World Data from Taiwan Shows Stage Shift Has Improved Lung Cancer Survival Rates

Pan-Chyr Yang, MD, PhD
+more
on: June 07, 2022In: Evolving Standards of Care, Industry News & Regulatory Approvals
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. Read more

US FDA’s Review of Single-Country ‘Me Too’ Drugs: A Clinical Trialist Perspective

Matthew Z. Guo, BA
+more
on: May 24, 2022In: Industry News & Regulatory Approvals
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. Read more

In Brief for May 25, 2022

Erin Jungmeyer
on: May 24, 2022In: Industry News & Regulatory Approvals, Meeting News, Names & News, Society News
In Brief for May 25, 2022

5th edition of patient education book released; US FDA moves to prohibit tobacco flavoring. Read more

In Brief for May 11, 2022

Erin Jungmeyer
on: May 11, 2022In: Industry News & Regulatory Approvals, Names & News
In Brief for May 11, 2022

Winship Cancer Institute announces preceptor opportunity. NICE recommends tepotinib for select patients. Read more

The FDA Explained: An Interview with Dr. Harpreet Singh

Lung Cancer Considered
on: March 23, 2022In: Industry News & Regulatory Approvals
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. Read more

US FDA greenlights nivolumab for use before surgery for NSCLC

Erin Jungmeyer
on: March 23, 2022In: Evolving Standards of Care, Industry News & Regulatory Approvals
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. Read more

Regulatory News for February 23, 2022

John Austin
on: February 23, 2022In: Industry News & Regulatory Approvals
Regulatory News for February 23, 2022

Taiwan OKs nivolumab IV infusion in some cases. UK approves atezolizumab for NSCLC. European Commission greenlights lorlatinib for advanced ALK-positive disease. Read more

Regulatory News for February 9, 2022

John Austin
on: February 09, 2022In: Industry News & Regulatory Approvals
Regulatory News for February 9, 2022

Sotorasib earns approval in European Union, Japan. Scotland OKs osimertinib. Read more

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