Diagnostic Center | December 17, 2024
Bayer announces positive topline resukts for Aflibercept 8 mg in phase III study
Demonstrates vision gains with extended treatment intervals in retinal vein occlusion
Demonstrates vision gains with extended treatment intervals in retinal vein occlusion
The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States
Yesafili, received marketing authorization approval from the European Commission for the European Union
The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway
Aflibercept is the second biosimilar product that has entered the clinical trial phase after biosimilar Adalimumab
Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME
The approval is based on a comprehensive package of analytical, nonclinical, and clinical data
YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
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