- Organizations: Bayer AG
Pipeline
FDA grants Orphan Drug designation to BlueRock's RP cell therapy
Marks second designation for OpCT-001; includes tax credits for qualified clinical testing and, if approved, 7 years of U.S. market exclusivity.Pipeline
Regeneron releases 2-year data on aflibercept 8 mg for DME
New findings support 1-year data of interval dosing maintenance; shows similarities to Eylea clinical data.Pipeline
FDA declines BLA approval for Regeneron's high-dose aflibercept
Agency bases response on an ongoing review of inspection findings at a third-party filler.Pipeline