FDA declines to approve pre-filled syringe version of Regeneron's Eylea

FDA declines to approve pre-filled syringe version of Regeneron's Eylea


REUTERS: Regeneron Pharmaceuticals Inc said on Thursday the U.S. Food and Drug Administration declined to approve a pre-filled syringe version of its blockbuster eye drug Eylea, and has sought additional information regarding its manufacturing and supply processes. The drugmaker said the rejection does not affect its earlier expectation of launching the product in 2019.



from Biotech News
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