Astellas submits new drug application for Zolbetuximab in Japan
Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers
Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
The new API plant is set up to meet all domestic and international regulatory standards and will manufacture niche molecules that have a global requirement
Lantern is receiving an exclusive and worldwide option to license intellectual property from Bielefeld University related to the collaboration and IP generated from the collaboration
In Phase 3 CCTG IND.227/KEYNOTE-483 trial, KEYTRUDA plus chemotherapy also demonstrated statistically significant improvements in PFS and ORR compared to chemotherapy alone
Olverembatinib is the first and only third-generation BCR-ABL inhibitor approved in China for the treatment of adult patients with tyrosine kinase inhibitors
This fresh infusion of capital will enable ImmunoACT to fast track the additional supply of the lead candidate HCAR-19
Capnopharm’s new CapnoPen is the first PIPAC nebulizer to obtain CE marking under the new MDR regulation 2017/745
The approval paves the way for consolidating the company’s position in Kenya and other African markets as part of its global expansion plans
First clinical trial reporting results of an mRNA therapeutic for intracellular protein replacement
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