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Home Industry News & Regulatory Approvals

Regulatory News for April 24, 2024

Erin Jungmeyer
on: April 23, 2024In: Industry News & Regulatory Approvals
Regulatory News for April 24, 2024

US FDA grants accelerated approval of HER2-targeting antibody drug conjugate; China accepts supplemental new drug application for savolitinib. Read more


US Food and Drug Administration Accepts New Drug Application for Ensartinib

Erin Jungmeyer
on: April 09, 2024In: Industry News & Regulatory Approvals
US Food and Drug Administration Accepts New Drug Application for Ensartinib

The filing was based on results from a global phase III study designed to compare the ALK inhibitor to crizotinib in the first-line treatment of ALK-positive NSCLC. Read more

Regulating Artificial Intelligence

Erin Jungmeyer
on: March 26, 2024In: Evolving Standards of Care, Industry News & Regulatory Approvals
Regulating Artificial Intelligence

The US FDA’s Dr. Harpreet Singh talks with ILCN about what the increasing use of AI means for the agency as it works to ensure drugs and devices are safe and effective. Read more

US FDA Grants Breakthrough Therapy Designation for Novel TKI Targeting HER2, EGFR

Erin Jungmeyer
on: March 26, 2024In: Industry News & Regulatory Approvals
US FDA Grants Breakthrough Therapy Designation for Novel TKI Targeting HER2, EGFR

The move was supported by preliminary evidence from a phase I, first-in-human study in patients with advanced NSCLC. Read more

US FDA Approves Frontline Amivantamab Combination for Patients with EGFR exon 20 Insertion-mutated NSCLC

Erin Jungmeyer
on: March 12, 2024In: Industry News & Regulatory Approvals
US FDA Approves Frontline Amivantamab Combination for Patients with EGFR exon 20 Insertion-mutated NSCLC

The agency also granted approval to amivantamab as a treatment for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations who progressed on or after platinum-based chemotherapy. Read more

US Approves Osimertinib with Chemotherapy for EGFR+ NSCLC; Approvals Pending in Other Countries

Erin Jungmeyer
on: February 27, 2024In: Industry News & Regulatory Approvals
US Approves Osimertinib with Chemotherapy for EGFR+ NSCLC; Approvals Pending in Other Countries

Other recent regulatory moves include the FDA granting full approval to tepotinib for metastatic NSCLC harboring MET exon skipping alterations and new applications for amivantamab in the US and Europe. Read more

Regulatory Approval Brings New Targeted Treatment Option for NSCLC to European Union

Erin Jungmeyer
on: February 13, 2024In: Industry News & Regulatory Approvals
Regulatory Approval Brings New Targeted Treatment Option for NSCLC to European Union

The European Commission recently approved adagrasib for KRAS G12C+ non-small cell lung cancer. Additionally, the US FDA has accepted a premarket approval application for tumor treating fields therapy. Read more

In Brief for November 8, 2023

Erin Jungmeyer
on: November 07, 2023In: Industry News & Regulatory Approvals
In Brief for November 8, 2023

October saw two approvals from the US FDA as well as caution from the agency’s Oncologic Drug Advisory Committee regarding the interpretation of CodeBreak 200 data; Takeda announces withdrawal of mobocertinib. Read more

In Brief for June 28, 2023

Erin Jungmeyer
on: June 27, 2023In: Industry News & Regulatory Approvals
In Brief for June 28, 2023

Canada to require health warnings on cigarettes. US FDA approves application for pemetrexed injection, grants priority review for repotrectinib. Read more

In Brief for May 24, 2023

Erin Jungmeyer
on: May 24, 2023In: Industry News & Regulatory Approvals, Meeting News
In Brief for May 24, 2023

Health Canada gives greenlight to cemiplimab-chemo combo for first-line treatment of advanced NSCLC. Early registration for WCLC 23 ends June 9. Read more

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