Regeneron faces FDA rejection and stock slump over manufacturing and contractor issues.

The FDA rejected Regeneron's new 8-mg version of Eylea due to an ongoing review of inspection findings at a third-party filler, dealing a major blow to the company's attempt to expand the use of its eye injection for the treatment of patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The company had sought to speed up the FDA's review of this application with a priority review voucher, which typically costs about $100 million.