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Aflibercept 8 mg (Eylea HD) Approved by FDA for wAMD, DME, and Diabetic Retinopathy

With approval, aflibercept 8 mg becomes the first and only treatment approved in wAMD and DME for immediate dosing at 8-week and up to 16-week intervals following 3 initial monthly doses. ....

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FDA Issues Complete Response Letter for Aflibercept 8 mg as AMD, DME Treatment

The letter makes reference to an ongoing review of inspection findings from a third-party filler involved with the drug development. Regeneron will not require additional trial data. ....

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