Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
VYVGART: Approval for Treatment of Myasthenia Gravis
Japan’s Ministry of Health, Labour, and Welfare (MHLW) has approved agrenx SE’s VYVGART (efgartigimod alfa) intravenous infusion for the treatment of generalized myasthenia gravis (gMG) in adult patients who did not see improvements from pervious treatment with...
Investigational New Drug: CX-904 To Treat Solid Tumors
The U.S. Food and Drug Administration (FDA) has granted clearance of CytomX and Amgen’s Investigational New Drug Application (IND) for CX-904, a T-cell-engaging bispecific antibody, to treat advanced solid tumors. Solid tumors can be malignant or benign, typically...
Diadem’s AlzoSure Predict: Breakthrough Device Designation
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Diadem’s AlzoSure Predict, a blood-based biomarker prognostic assay designed to identify early signs of Alzheimer’s disease and determine the potential rate of progression in...
FDA Approval: AbbVie’s RINVOQ to Treat Atopic Dermatitis
AbbVie has announced the U.S. Food and Drug Administration (FDA) approval for RINVOQ (upadacitinib) to treat refractory, moderate to severe atopic dermatitis in children 12 years and older and adults. Atopic dermatitis, more commonly known as eczema, is a chronic skin...
FDA IND Clearance: Topical Agent to Treat Dry Eye Disease
The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for Aramis Biosciences’ immunomodulatory agent, A197, for the treatment of dry eye disease. Dry eye disease is a common, chronic, immune-mediated disease that is...
CBMG: FDA Designations for Cell Therapy to Treat DLBCL
The U.S. Food and Drug Administration (FDA) has granted both a Fast Track Designation and a Regenerative Medicine Advanced Therapy Designation (RMAT) to Cellular Biomedicine’s (CBMG) autologous b-specific therapy, C-CAR039, for the treatment of patients with diffuse...
FDA IND Approval: SNIPR001 to Target E. coli Infections
SNIPR BIOME has announced the U.S. Food and Drug Administration (FDA) has approved their Investigational New Drug (IND) application for SNIPR001 to target E. coli infections in cancer patients. E. coli bacteria live in the intestines of healthy people and while most...
Advanced NSCLC: EC Approval of Lumykras Treatment
The European Commission (EC) has granted a conditional marketing authorization for Amgen’s LUMYKRAS (sotorasib) to treat advanced non-small cell lung cancer (NSCLC) with the KRAS G12C mutation in adults. NSCLC is the leading lung cancer diagnosis globally and includes...
FDA sNDA: REXULTI to Treat Pediatric Schizophrenia
The U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Otsuka and H. Lundbeck’s drug REXULTI for the treatment of schizophrenia in pediatric patients aged 13 to 17. Schizophrenia is a life-long serious disease that is...
European Commission: ODD for ASTX727 to Treat AML
The European Commission (EC) has granted orphan-drug designation (ODD) for Astex Pharma’s oral fixed dose ASTX727 to treat Acute Myeloid Leukemia (AML). AML, a blood cancer characterized by the overproduction of immature white blood cells within the bone marrow, is...
Categories
ABOUT US
CSOFT Health Sciences has over 15 years of experience providing end-to-end translation and localization solutions for all stages of the product life cycle, from pre-clinical to post-launch. We also specialize in China market access consulting services, Asian regulatory and eCTD submissions. Our operation is compliant with ISO 17100 and certified by BSI in ISO 9001:2015 and ISO 13485:2016, providing customized solutions to meet the rigorous regulatory requirements in global submission. For more information, please visit: www.csoftintl.com