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FDA Approves Third Lucentis® (ranibizumab) Interchangeable Biosimilar: Formycon’s Nufymco™
12 Jan 2026 23:36 GMT
… , 2025, the FDA approved Formycon and Zydus’s Nufymco™ (ranibizumab-leyk) as … biosimilar of Genentech’s Lucentis® (ranibizumab). Lucentis® biosimilars have been on … Q2 2025 when interchangeable Cimerli™ (ranibizumab-eqrn) commercialization was paused for …
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Region-Specific Retinal and Choroidal Biomarkers Associated with Visual Outcomes After Anti-VEGF Treatment in Center-Involved Diabetic Macular Edema
12 Jan 2026 09:43 GMT
… patients in clinical trials demonstrate suboptimal … -LM2021010J), Innovative Pharmaceutical and Medical Device Products Application … macular thickening after ranibizumab treatment for diabetic macular … a randomized clinical trial. Invest Ophthalmol Vis …
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Real-World Study Finds Stable Vision After Switch to Ranibizumab Biosimilar
07 Jan 2026 21:08 GMT
… effective alternative for long-term treatment.” The investigators also noted … . Seeing eye to eye: FDA's Dr Sarah Yim … 47;seeing-eye-to-eye-fda-s-dr-sarah-yim-discusses … -vascular endothelial growth factor drugs to ranibizumab biosimilar in neovascular age …
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FDA Issues Complete Response Letter for Outlook’s Wet AMD Therapy
06 Jan 2026 12:48 GMT
… #47;LYTENAVA (bevacizumab-vikg), stating that the application cannot be … from the NORSE clinical trial program. This included NORSE … efficacy data from other trials in the program. Among … comparing ONS-5010 with ranibizumab in treatment-naïve wet AMD patients …
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Posterior Vitreous Detachment Determines the Clinical Impact of Fibrovascular Membrane Fibrosis After Anti-VEGF Treatment in Proliferative Diabetic Retinopathy: A Real-World Study
06 Jan 2026 18:14 GMT
… Most randomized controlled trials involve patients … glaucoma refractory to medical treatment; (4) a … Treatment Protocol
All patients received intravitreal anti-VEGF injections using ranibizumab … clinical trial evaluating intravitreal ranibizumab or saline …
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<![CDATA[FDA issues third rejection of bevacizumab to treat wet AMD]]>
02 Jan 2026 23:13 GMT
… data from all other NORSE trials. The resubmission also included … Lucentis (ranibizumab) in a 12-week study of treatment naïve patients … efficacy results from this trial indicated that ONS-5010 … protocol assessment with the FDA.
Outlook Therapeutics once again …
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Outlook Therapeutics receives FDA response on ONS-5010 for wet AMD
02 Jan 2026 08:54 GMT
… the US Food and Drug Administration’s (FDA) complete response letter … 5010 and ranibizumab in a 12-week trial of treatment-naïve … the EU and the Medicines and Healthcare products Regulatory … Action
Awarded the 2025 Pharmaceutical Technology Excellence Award for …
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Samsung Bioepis Begins Commercialization of BYOOVIZ®, Biosimilar to Lucentis (Ranibizumab), in Europe
02 Jan 2026 08:38 GMT
… ®, a biosimilar to Lucentis1 (ranibizumab), in Europe. Samsung Bioepis … seamless access to our biosimilar medicines for patients in need.” … 0.05 ml) for the treatment of neovascular (wet) age … ). In November 2025, European Medicines Agency (EMA)’s Committee for …
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FDA Issues Complete Response Letter for ONS-5010 for Wet AMD
31 Dec 2025 22:46 GMT
… the US Food and Drug Administration (FDA) has issued a Complete … of bevacizumab for the treatment of wet AMD. Bevacizumab … on the NORSE EIGHT trial results, as well as … thickness between ONS-5010 and ranibizumab. After analysis, investigators announced …
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<![CDATA[FDA Issues Complete Response Letter for ONS-5010 for Wet AMD]]>
31 Dec 2025 22:46 GMT
… the US Food and Drug Administration (FDA) has issued a Complete … of bevacizumab for the treatment of wet AMD. Bevacizumab … on the NORSE EIGHT trial results, as well as … thickness between ONS-5010 and ranibizumab. After analysis, investigators announced …
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