Drug Designation for AO-176: Treatment for Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Arch Oncology’s next-generation anti-CD47 IgG2 antibody, AO-176, for the treatment of relapsed/refractory multiple myeloma (r/r MM). Multiple myeloma is a cancer of mature plasma...
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...