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The FDA Friday approved a second indication for Regeneron Pharmaceuticals’ Eylea to treat macular edema following central retinal vein occlusion (CRVO).
Amgen has won FDA approval on a new indication for Prolia to increase bone mass in men with osteoporosis at high risk for fracture.
Mylan has received FDA approval for its valsartan and hydrochlorothiazide tablets, the first generic version of Novartis’ Diovan HCT tablets.
The EU’s Committee for Medicinal Products for Human Use (CHMP) is recommending approval of four new drugs, including Regeneron’s Eylea for wet age-related macular degeneration (AMD).
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