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Home Industry News & Regulatory Approvals

Updated Data Show Median OS of 16.9 months in Patients with Advanced NSCLC Treated with THIO

Haleigh Behrman
on: March 11, 2025In: Evolving Standards of Care, Industry News & Regulatory Approvals, Society News
Updated Data Show Median OS of 16.9 months in Patients with Advanced NSCLC Treated with THIO

Though the study is small, the sponsor says results are promising for the first-in-class telomere-targeting agent. Read more


US FDA Grants Priority Review for Zongertinib for Advanced HER2+ NSCLC

Haleigh Behrman
on: March 11, 2025In: Evolving Standards of Care, Industry News & Regulatory Approvals, Society News
US FDA Grants Priority Review for Zongertinib for Advanced HER2+ NSCLC

Data from the Beamion LUNG-1 trial show a 71% objective response rate in previously treated patients. Read more

In Brief for February 26, 2025

Haleigh Behrman
on: February 25, 2025In: Evolving Standards of Care, Global Initiatives, Industry News & Regulatory Approvals
In Brief for February 26, 2025

Durvalumab is recommended for approval in the EU, Health Canada approves pembrolizumab, and the US FDA grants priority review to datopotamab deruxtecan. Read more

New Combination Therapies Mean More Options, Challenge Decision-Making

Haleigh Behrman
on: February 11, 2025In: Evolving Standards of Care, Industry News & Regulatory Approvals, Society News
New Combination Therapies Mean More Options, Challenge Decision-Making

Dr. Susan Scott discusses how findings from the MARIPOSA and FLAURA-2 trials will be incorporated into clinical practice. Read more

In Brief for February 12, 2025

Haleigh Behrman
on: February 11, 2025In: Global Initiatives, Industry News & Regulatory Approvals
In Brief for February 12, 2025

The US FDA grants fast track designation to treat KRAS G12C-mutant metastatic NSCLC and China’s NMPA approves taletrectinib for advanced ROS1-positive NSCLC. Read more

In Brief for January 22, 2025

Haleigh Behrman
on: January 21, 2025In: Global Initiatives, Industry News & Regulatory Approvals, Society News
In Brief for January 22, 2025

FDA issues draft guidance on the use of AI for biological and drug product submissions, China’s NMPA grants priority review for the combination of savolitinib and osimertinib, and nivolumab and hyaluronidase-nvhy receive FDA approval for subcutaneous injection. Read more

In Brief for January 8, 2025

Haleigh Behrman
on: January 07, 2025In: Industry News & Regulatory Approvals
In Brief for January 8, 2025

The US FDA approves ensartinib for ALK-positive NSCLC and provides an updated regulatory review of subcutaneous amivantamab. Read more

In Brief for December 18, 2024

Haleigh Behrman
on: December 17, 2024In: Industry News & Regulatory Approvals
In Brief for December 18, 2024

European Medicines Agency recommends repotrectinib for ROS1-positive NSCLC; FDA approves therapies for NSCLC, LS-SCLC as well as a new diagnostic tool for identifying MET exon 14 skipping alterations. Read more

In Brief for October 9, 2024

Haleigh Behrman
on: October 08, 2024In: Industry News & Regulatory Approvals
In Brief for October 9, 2024

US FDA greenlights subcutaneous atezolizumab, grants Breakthrough Therapy Designation for novel antibody drug conjugate to treat SCLC. Read more

In Brief for September 25, 2024

Haleigh Behrman
on: September 24, 2024In: Industry News & Regulatory Approvals
In Brief for September 25, 2024

Fulzerasib becomes the first KRAS G12C inhibitor approved in China. Encorafenib receives approval from the European Commission. The US FDA grants priority review and breakthrough therapy designation to durvalumab for SCLC. Read more

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