FDA approves 12-week Eylea regimen after short delay

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA approved an sBLA for an every 12-week dosing schedule of Eylea aflibercept in wet age-related macular degeneration (AMD).

The agency's green light comes just days after Regeneron revealed a complete response letter Monday for the sBLA, which it attributed to ongoing labeling discussions. At the time, the company said it expected to complete discussions and receive a final action from FDA within about two months (see "Delay for Regeneron's 12-Week Eylea Regimen")...