Tagged as: approval

FDA Approves Genentech’s VABYSMO for Wet AMD and Diabetic Macular Edema

On January 28, 2022, the Food and Drug Administration (FDA) approved Genentech’s VABYSMO (faricimab-svoa) for the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). According to the Genentech press release, VABYSMO targets and neutralizes angiopoietin-2 (ang-2) and vascular endothelial growth factor-A (VEGF-A). The press release also…

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Biosimilars Approvals: Nepexto Receives European Marketing Authorization, Ziextenzo and Riximyo Receive Health Canada Approval

Last week, Lupin and Mylan announced that the European Commission had granted marketing authorization for their biosimilar Nepexto (etanercept) for all indications of the reference product.  The marketing authorization follows a positive opinion from the Committee for Medicinal Products for Human Use earlier this year based on preclinical and clinical…

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