Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
Harnessing advanced data analysis for early detection, prevention and better outcomes
First and only PARP inhibitor to improve overall survival in early breast cancer
Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
First patient enrolled in the Phase III SOHO-02 trial of investigational agent BAY 2927088 in treatment-naïve patients with advanced NSCLC with HER2-activating mutations
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