U.S. FDA declines to approve pre-filled syringe version of Regeneron's Eylea [Reuters]
Regeneron Pharmaceuticals, Inc. (REGN)
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Source: Reuters
FDA declines to approve pre-filled syringe version of Regeneron's Eylea | Reuters 2 Min Read (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. It plans to resubmit its application early next year. Regeneron told Reuters the regulator has also asked for the completion of a small study, involving about 30 patients, to demonstrate doctors are able to administer the product. Eylea has made Regeneron a dominant player in the eye-disease space and brought in sales of $3.70 billion in the United States last year. But with Swiss drugmaker Roche AG’s prefilled syringe rival treatment threatening market share, Regeneron has thrown marketing heft behind Eylea and pushed for i
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REGN
Earnings
- 2/2/24 - Beat
REGN
Sec Filings
- 4/3/24 - Form 4
- 4/3/24 - Form 4
- 4/1/24 - Form 144
- REGN's page on the SEC website