FDA, Roche and Susvimo

FDA expands label for Roche's eye disease implant Susvimo
The new indication adds to the 2021 approval of Susvimo (ranibizumab) for 'wet' or neovascular age-related macular degeneration (AMD), and comes just a few months after Roche returned the drug to the US market after a two-year hiatus.
FDA approves Roche’s Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness
Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME)With as few as two treatments per year, Susvimo may help people with DME maintain their visionApproval marks the second indication for Susvimo in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD) Basel,
FDA approves Roche’s Susvimo for DME
The US Food and Drug Administration (FDA) has approved Susvimo (ranibizumab injection) 100mg/mL for the treatment of diabetic macular edema (DME), said Swiss pharma giant Roche.
FDA approves continuous delivery ranibizumab injection (Susvimo) for the treatment of diabetic macular edema
Susvimo 100 mg/mL for intravitreal use via ocular implant is a refillable implant surgically inserted into the eye during a one-time, outpatient procedure, continuously delivering a customized formulation of ranibizumab over time.
FDA Approves Susvimo for Diabetic Macular Edema
Susvimo is also approved to treat age-related macular degeneration, and the medication, ranibizumab, is delivered though a refillable ocular implant.
FDA Approves Roche’s Susvimo Refillable Eye Implant for Diabetic Macular Edema
Roche’s Susvimo, a refillable eye implant for diabetic macular edema, provides continuous delivery of ranibizumab, showing sustained vision improvements with fewer treatments than standard eye injections.
With FDA approval, Genentech turns eye implant's focus to diabetes
Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already-approved drug to head off the leading cause of blindness in people with diabetes.
Roche gains label expansion for eye implant Susvimo to treat diabetic macular edema
Seven months after the FDA signed off on a reintroduction of Roche’s eye implant Susvimo, the U.S. regulator has broadened its label as a treatment for diabetic macular edema (DME), which is the leading cause of diabetes-related blindness.
Roche announces FDA approves Susvimo to treat DME
Roche (RHHBY) announced that the Food and Drug Administration has approved Susvimo 100 mg/mL for the treatment of diabetic macular edema, a
FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Susv
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FDA approves ranibizumab for treating diabetic macular edema
The U.S. Food and Drug Administration (FDA) has approved ranibizumab injection (Susvimo, 100 mg/mL; Genentech) for the ...
Genentech : FDA Approves Susvimo For Diabetic Macular Edema Treatment
Genentech, a member of the Roche Group (RHHBY), announced that the U.S. Food and Drug Administration has approved Susvimo ...