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
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes
Infections with H. pylori affect over 43 percent of the world’s population with a wide range of gastrointestinal disorders
Mankind Pharma will have exclusive rights to register, import, market, sell and distribute sintilimab in India
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
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