News about "sevabertinib"

US FDA Grants Priority Review to HYRNUO for HER2-Mutated NSCLC

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 105

MHRA Approves Bayer's Sevabertinib for HER2-Mutated Advanced Lung Cancer

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 141

Bayer Secures Breakthrough Status for Sevabertinib in HER2 NSCLC

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 322


 

 

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