Biotechnology company Genentech, part of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), announced on Friday that it has secured US Food and Drug Administration (FDA) approval for its Vabysmo (faricimab-svoa) prefilled syringe for treating three retinal conditions that can cause blindness.
The Vabysmo 6.0 mg single-dose prefilled syringe (PFS) is indicated for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect almost three million people in the United States.
Designed to simplify administration, Vabysmo PFS offers retina specialists a ready-to-use option. It delivers the same medication as existing Vabysmo vials.
Vabysmo has already gained approval in over 95 countries for wet AMD and DME, with RVO approvals in selected regions.
Johnson & Johnson submits New Drug Application for TAR-200 to treat bladder cancer
Phase I/II clinical trial of Ariceum Therapeutics' 225Ac-SSO110 gets US FDA approval
Adaptive Biotechnologies and NeoGenomics partner to expand MRD monitoring for blood cancer
BioArctic reports FDA acceptance of BLA for for subcutaneous maintenance dosing of Leqembi
Elicera Therapeutics receives ODD for ELC-100
ReciBioPharm secures grant to expand RNA manufacturing in LMICs
Johnson & Johnson agrees acquisition of Intra-Cellular Therapies Inc