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News about "sevabertinib"
US FDA Grants Accelerated Approval to Sevabertinib for Advanced NSCLC
The US Food and Drug Administration (FDA) has granted accelerated approval to sevabertinib for locally advanced or metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) with HER2 (ERBB2) TKD activating mutations.
Sevabertinib | 11/09/2026 | By News Bureau
Japan Approves Bayer's Sevabertinib for HER2-Mutant NSCLC
Japan approves Bayer’s sevabertinib as the first targeted therapy for HER2-mutant NSCLC, including first-line use, based on phase 1/2 SOHO-01 results.
Sevabertinib | 25/08/2026 | By News Bureau | 120
US FDA Grants Priority Review to HYRNUO for HER2-Mutated NSCLC
The US FDA has granted Priority Review (PR) to HYRNUO (sevabertinib) as a first-line treatment for HER2-mutated Non-Small Cell Lung Cancer (NSCLC), based on phase 1/2 SOHO-01 trial data.
Sevabertinib | 21/05/2026 | By News Bureau | 152
MHRA Approves Bayer's Sevabertinib for HER2-Mutated Advanced Lung Cancer
Sevabertinib, a targeted therapy for HER2-mutated lung cancer, has been approved by the UK regulator to expand treatment options for advanced-stage patients.
Sevabertinib | 04/04/2026 | By News Bureau | 195
Bayer Secures Breakthrough Status for Sevabertinib in HER2 NSCLC
US FDA and China’s CDE granted the designation for sevabertinib as a potential first-line therapy in advanced HER2-mutant non-small cell lung cancer.
Sevabertinib | 07/01/2026 | By News Bureau | 421
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