Sevabertinib, a non-covalent inhibitor of the HER2 kinase, shows activity in preclinical cancer models with genomic activation of ERBB2 and for patients with HER2-mutant lung cancer.

Global bupivacaine hydrochloride API market was valued at USD 93.6 million in 2025 and is projected to reach USD 135.9 million by 2034, CAGR 4.21%.

FDA has granted accelerated approval to sevabertinib (Hyrnuo), a kinase inhibitor, for adult patients with locally advan

FDA granted accelerated approval to sevabertinib (Hyrnuo), a kinase inhibitor, for adult patients with locally advanced

The good news The U.S. Food and Drug Administration (FDA) has granted accelerated approval to sevabertinib for the treatment of adult patients with unresectable or metastatic non-squamous non-small…

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to sevabertinib, an oral targeted therapy from Bayer, for adults with locally advanced or metastatic non-squamous non-small

Reported Wednesday, Sep 9 - 11:38am EDT (TheFly subscription required to read more.)

The pharma division of Bayer has quietly become the company’s most reliable source of good news. The latest development arrived this week when Japanese regulators granted marketing approval for Sevabertinib, the company’s targeted therapy for HER2-mutant non-small cell lung cancer (NSCLC). Sold under the brand name Hyrnuo in Japan, the drug has secured a clearance [...] The post Bayer’s Oncology Pipeline Gains Traction in Japan, Yet the Glyphosate Clock Keeps Ticking appeared first on NewsCase .

The MHLW approval covers all lines of therapy, including first-line use, in unresectable advanced or recurrent HER2-mutant NSCLC.

Experts in lung cancer gathered at an OncLive® Scientific Interchange and Workshop during the 2026 ASCO Annual Meeting to discuss HER2-mutated NSCLC.

FDA has granted Hyrnuo (sevabertinib) priority review status for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations in patients with no prior therapy. To access this subscriber-only content please log in or subscribe.If your institution has a site […]

The FDA approved Dato-DXd for PD-1/PD-L1–ineligible triple-negative breast cancer, granted priority review to sevabertinib in HER2-mutant NSCLC, and more.

The FDA has granted priority review to a supplemental new drug application for sevabertinib, an investigational treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSC