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.
HYRNUO | 21/05/2026 | By News Bureau | 105
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.
Hyrnuo | 04/04/2026 | By News Bureau | 141
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.
Hyrnuo | 07/01/2026 | By News Bureau | 322
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