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Regeneron Pharmaceuticals, Inc.: Regeneron Provides Update on EYLEA HD (aflibercept) Injection 8 mg Supplemental Biologics License Application
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter ...
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Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria
PARIS, France and TARRYTOWN, NY, USA I April 18, 2025 I The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of ...
Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application
EYLEA ® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion ...
Regeneron to Reassess Strategy for Retinal Condition Treatment After FDA Rejects Dosing Plan
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 ...
Dupixent® (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU)
Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo In the U.S., there are more than ...
Regeneron, Sanofi Get FDA Approval For Dupixent in Skin Disease CSU
Regeneron Pharmaceuticals and Sanofi won U.S. Food and Drug Administration expanded approval of their blockbuster anti-inflammatory drug Dupixent for the inflammatory skin condition chronic ...
Regeneron announces FDA accepted Priority Review sBLA for EYLEA HD
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 ...
Regeneron, Sanofi announce FDA approval of Dupixent for CSU
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the U.S. Food and Drug Administration has approved Dupixent for the treatment ...
The Pharma Letter3d
Eylea HD injection 8mg sBLA accepted for FDA Priority Review
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) Injection 8mg, submitted by US biotech ...
Upstream Bio: Verekitug, A Longer-Acting Dupixent? - Key Data Is Imminent
The company has a strong cash position of $471m, despite a net loss of $63m in 2024, providing a long funding runway. Click ...