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Susvimo, FDA and Roche
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.
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.
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
With FDA approval, Genentech turns eye implant's focus to diabetes
Genentech initially won Food and Drug Administration approval of the refillable implant in 2021 for patients with we
Ibj.com
7h
Roche gets FDA clearance for test of emerging cardiovascular disease risk
Lipoprotein(a) has long been recognized as a critical marker for people at risk of cardiovascular disease. However, the health care industry has lacked the tools to tackle the problem.
6d
Wafaa Mamilli To Join Roche As Chief Digital Technology Officer
Wafaa Mamilli will join Roche as the company's new Chief Digital Technology Officer in February. This follows expansive roles ...
6d
on MSN
Roche Expects Sales, Earnings Growth After Better-Than-Expected Results
The company expects sales and core earnings to keep growing this year after beating analysts’ expectations for 2024, and the ...
devdiscourse
2d
Roche Remains Unfazed Amid Trade Tariffs
Roche, a Swiss pharmaceutical company, anticipates no significant business impact from recent U.S. trade tariffs on Mexico, ...
FierceBiotech
6d
Roche drops HER2 bispecific, Xencor-partnered cytokine from early-phase pipeline
Roche has given two early-phase bispecifics the heave-ho, ending work on a HER2xCD3 prospect and an IL-15 candidate it picked ...
1d
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 ...
6d
on MSN
Roche sees high single-digit core profit growth in 2025
Roche said on Thursday it is targeting a continued increase in adjusted earnings per share (EPS) at a high single-digit ...
FierceBiotech
1d
Roche's Enhertu companion diagnostic secures new FDA approval in HER2-ultralow breast cancer
Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...
5d
Roche Q4 Earnings Review: Solid All-Court Performance, But Quiet On GLP-1 Progress
Roche Holding AG delivered a strong set of 2024 earnings. Guidance for 2025 suggests this will be a transitional year ahead, ...
6d
Roche Bobois Slightly Misses 2024 Revenue Guidance, Says China Boosted Q4
The upscale French furniture-maker posted preliminary revenues of 414 million euros for the full year, but said its fourth ...
4h
on MSN
Why haven't the Red Sox signed Alex Bregman?
Dan Roche offers up a plan for the Red Sox to go out and sign Alex Bregman, which he believes would solidify Boston as a ...
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Susvimo
Enhertu
Food and Drug Administration
Diabetic retinopathy
HER2/neu
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