Approval based on AEGEAN Phase III trial results which showed a 32% reduction in the risk of recurrence, progression or death vs. neoadjuvant chemotherapy alone
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
BRAFTOVI combination regimen is the first and only targeted therapy approvedby the U.S. FDA for treatment-naïve patients with metastatic colorectal cancer with a BRAF V600E mutation
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
Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR
Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years
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