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
Survey of Unmet Needs in chronic myeloid leukemia (CML SUN) data signal need for amplified patient voice during treatment discussions that balance quality of life (QoL), efficacy, and tolerability goals across all lines of therapy
Chinook Therapeutics is a clinical-stage biopharmaceutical company with two high-value, late-stage assets in development for IgA nephropathy (IgAN), a rare, progressive chronic kidney disease
Coverage of CGHS cities has expanded from 25 cities in 2014 to 80 in 2023
The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52
Acquisition accelerates Cosette’s women’s health portfolio; with a differentiated, commercial stage, patent protected product
New facility will strengthen the security of supply for global pharmaceutical and biotech customers and will support the continued development and production of lifesaving clinical and commercial-scale therapeutics for patients worldwide.
Construction will begin this year with the new capacity anticipated by 2025
The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations
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