News | July 31, 2025
Imfinzi granted Priority Review and Breakthrough Therapy Designation in US
For patients with resectable early-stage gastric and gastroesophageal junction cancers
For patients with resectable early-stage gastric and gastroesophageal junction cancers
This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition
Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure
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
Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A
Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy
Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure
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