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Home Industry News & Regulatory Approvals

In Brief for June 11, 2025

Haleigh Behrman
on: June 10, 2025In: Industry News & Regulatory Approvals, Society News
In Brief for June 11, 2025

VENTANA MET (SP44) RxDx Assay receives FDA approval as a companion diagnostic for telisotuzumab vedotin-tllv in patients with high c-MET overexpression in NSCLC. Read more


Research to Watch: CAN-2409 Demonstrates Survival Benefit in Patients with Advanced NSCLC Unresponsive to ICIs

Haleigh Behrman
on: May 27, 2025In: Industry News & Regulatory Approvals, Society News
Research to Watch: CAN-2409 Demonstrates Survival Benefit in Patients with Advanced NSCLC Unresponsive to ICIs

According to recent phase II data, the experimental treatment demonstrated a median overall survival of 24.5 months. Read more

In Brief for May 28, 2025

Haleigh Behrman
on: May 27, 2025In: Industry News & Regulatory Approvals, Society News
In Brief for May 28, 2025

The US FDA grants accelerated approval to telisotuzumab vedotin-tllv for advanced NSCLC with high c-Met overexpression. Read more

In Brief for May 14, 2025

Haleigh Behrman
on: May 13, 2025In: Industry News & Regulatory Approvals, Society News
In Brief for May 14, 2025

Pembrolizumab-chemotherapy combo receives Canadian approval for first-line treatment of malignant pleural mesothelioma. Read more

In Brief for April 23, 2025

Haleigh Behrman
on: April 22, 2025In: Industry News & Regulatory Approvals
In Brief for April 23, 2025

The US FDA announces the approval of two IND applications, as well as for bevacizumab-nwgd. Read more

Foritinib Gains Momentum in China for ALK-positive NSCLC

Haleigh Behrman
on: April 08, 2025In: Evolving Standards of Care, Industry News & Regulatory Approvals, Society News
Foritinib Gains Momentum in China for ALK-positive NSCLC

China’s NMPA accepts a marketing authorization application for foritinib following interim results from the phase III REMARK trial. Read more

Zipalertinib Meets Primary Endpoint in Phase 2b Trial

Nathan Pettengill
on: March 25, 2025In: Industry News & Regulatory Approvals, Society News
Zipalertinib Meets Primary Endpoint in Phase 2b Trial

The drug’s developers have said the data show a positive overall response rate in previously treated patients with NSCLC with EGFR exon 20 insertion mutations. Read more

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

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