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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
FierceBiotech
18h
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 ...
17h
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 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 ...
5d
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 ...
devdiscourse
1d
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 ...
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 ...
Pharm Exec
19h
FDA Approves Expanded Label for Roche's Companion Diagnostic to Identify HER2-Ultralow Breast Cancer Patients Eligible for Enhertu
The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...
GlobalData on MSN
4d
Roche targets continued growth after strong 2024 sales
Roche has reported a 7% increase in full-year 2024 sales at constant exchange rates (CER), reaching CHF 60.5bn ($66.9bn). The ...
5d
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 ...
Moscow-Pullman Daily News
2h
Wind farm company: The community would benefit
The wind farm is projected to have a 30-year lifespan. Roche said the company doesn’t intend to sell, and will be with the ...
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Susvimo
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Enhertu
Food and Drug Administration
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