The FDA told Regeneron in a complete response letter that while it didn't identify any issues with the safety or efficacy of the drug in its approved indications and dosing regimens, the agency didn't ...

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License ...

Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo In the U.S., there are more than ...

Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for EYLEA HD Injection 8 mg. The sBLA seeks ...

If approved, Eylea would be the first treatment for RVO with 8-week dosing. The FDA target action date is Aug. 19, 2025.

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept injection 8mg for the treatment of macular edema following ...

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 US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application ...

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

Regeneron Pharmaceuticals has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its Eylea HD eye drug.

Lined up for the FDA in the coming weeks are a cell-based gene therapy for a rare skin disease and two product expansions for ...

Celltrion Inc. said Wednesday it has received regulatory approval from Australia’s Therapeutic Goods Administration (TGA) for ...