Off-label drug use stories

FDA Approves Outlook Therapeutics' LYTENAVA as First Branded Bevacizumab for Wet AMD After Fourth Attempt

The U.S. Food and Drug Administration has approved LYTENAVA (bevacizumab-vikg) for treating neovascular age-related macular degeneration (wet AMD), marking the first FDA-approved ophthalmic formulation of bevacizumab after 20 years of off-label use. The approval comes on Outlook Therapeutics' fourth regulatory attempt, though the company faces cash constraints as it enters commercialization.