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Biocon Biologics gains FDA approval for Yesafili, shares up
Biocon Biologics Ltd, a subsidiary of Biocon Ltd, secured U.S. FDA approval for Yesafili, an interchangeable biosimilar to Eylea (aflibercept). Yesafili is designed to treat ophthalmological conditions, including neovascular age-related macular degeneration, visual impairment due to macular edema secondary to retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization.
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Glenmark gets FDA approval for Ophthalmic solution, shares up
Glenmark Pharmaceuticals Ltd. secured final approval from the United States Food & Drug Administration (FDA) for its Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%|0.5%. The company informed that the solution was deemed bioequivalent and therapeutically equivalent to Combigan Ophthalmic Solution, 0.2%|0.5%, produced by AbbVie, Inc. Glenmark Pharmaceuticals Inc., USA will distribute the product in the US.