The going has been good for the German pharmaceutical giant Bayer BAYRY this year. Shares have surged 62.9% year to date ...

High-dose Eylea, or aflibercept 8 mg, is being jointly developed by Regeneron and Bayer AG. Regeneron shares were down 1.3% Tuesday before being halted in advance of the news.

Regeneron (REGN) announces FDA review of sBLA for Eylea HD to treat macular edema and expand dosing. Read more here.

The FDA did not agree with Regeneron’s proposal to add additional extended dosing intervals (greater than every 16 weeks, which is the maximum dosing interval currently indicated in the label).

The FDA will allow a new dosing schedule for Eli Lilly’s Alzheimer’s drug Kisunla that could lessen a known side effect of ...

The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application (sBLA) for Eylea HD (aflibercept) injection 8mg for priority review.

Bayer has been given a leg up in the competitive market for VEGF therapies used to treat eye diseases with a new EU approval for Eylea 8mg.

FDA accepts Regeneron's sBLA for Eylea HD in RVO with priority review; QUASAR data supports monthly dosing, target action date set for August 2025.

The FDA did not agree with Regeneron’s proposal to add additional extended dosing intervals (greater than every 16 weeks, which is the maximum dosing interval currently indicated in the label).