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Kodiak Drugs Clear Phase 3 for Wet AMD and Shares Soar

The company said it will seek U.S. approval by filing a Biologics License Application for Zenkuda in Q4 to pursue its first commercial product.

Definium’s LSD-Based Therapy Posts Third Positive Phase 3 Result in GAD

Moderna and Merck Personalized mRNA Vaccine Cuts Melanoma Recurrence in Phase 3 Readout

Lilly Will Seek FDA Approval for Retatrutide in Q1 2027 After Two More Positive Phase 3 Trials

Pfizer’s Elrexfio Posts Phase 3 PFS Win Over Standard Multiple Myeloma Regimen

FDA Clears Once-Weekly Saphnelo Pen for Self-Injection in Lupus

Insmed Halts Brensocatib in Hidradenitis Suppurativa After Phase 2b Trial Fails

Eupraxia Reports Early EoE Trial Data With Near‑Normal Tissue at Top Dose

FDA Clears Arrowhead’s Redemplo for FCS, Marking the Biotech’s First Approval

Pluvicto Added to Standard Care Extends rPFS in PSMA-Positive Metastatic Hormone-Sensitive Prostate Cancer

Phase 3 Trial Finds Tukysa Improves PFS in First-Line Maintenance for HER2-Positive Metastatic Breast Cancer

Eli Lilly Halts Diabetes Arm of Bimagrumab Obesity Trial Weeks After Launch

FDA Halts Rocket’s RP-A501 Gene Therapy for Danon Disease After Patient’s Death