Industry News & Regulatory Approvals
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In Brief: July 23, 2025
The US FDA grants Orphan Drug Designation to CID-078 for SCLC, and zidesamtinib demonstrates positive early data in ROS1-positive NSCLC.
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In Brief for July 9, 2025
The FDA grants accelerated approval to Dato-DXd, while a Biologics License Application for HER3-DXd is voluntarily withdrawn.
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Research to Watch: FDA Grants ZL-1310 Fast Track Designation for Extensive-Stage SCLC
ZL-1310 earns Fast Track Designation as a potential first-in-class DLL3-targeted ADC for extensive-stage small cell lung cancer.
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In Brief for June 25, 2025
The US FDA recently granted approval to taletrectinib for ROS1-positive NSCLC and accepted a priority review for lurbinectedin plus atezolizumab for ES-SCLC in the first-line setting.
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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.
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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.
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In Brief for May 28, 2025
The US FDA grants accelerated approval to telisotuzumab vedotin-tllv for advanced NSCLC with high c-Met overexpression.
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In Brief for May 14, 2025
Pembrolizumab-chemotherapy combo receives Canadian approval for first-line treatment of malignant pleural mesothelioma.
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In Brief for April 23, 2025
The US FDA announces the approval of two IND applications, as well as for bevacizumab-nwgd.
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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.
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