Artiva’s AlloNK Advances to Phase 3 Trial in Refractory Rheumatoid Arthritis
Artiva's AlloNK advances to Phase 3 trial in refractory rheumatoid arthritis with FDA-aligned design. 150-patient study compares allogeneic NK...
Atsena Advances XLRS and LCA1 Gene Therapies to Phase 3 Trials
Atsena advances XLRS and LCA1 gene therapies to Phase 3 trials, with foveal schisis closure maintained at 12 months...
Celldex’s Barzolvolimab Phase 3 CSU Trial Enrolls 1,939 Patients Across 43 Countries
Celldex's barzolvolimab Phase 3 CSU trial enrolls 1,939 patients across 43 countries, the largest antihistamine-refractory urticaria study ever conducted.
FDA Approves Efgartigimod Alfa for All Serological Types of Generalized Myasthenia Gravis
FDA approves efgartigimod alfa for generalized myasthenia gravis across all serological types, including triple-seronegative patients previously without labeled
The FDA’s One-Day Inspection Pilot Will Catch Sites That Aren’t Ready — Starting Now
FDA's BRIDGE one-day assessment pilot launched April 2026, compressing traditional 3-6 day inspections. Here's what sites must change before...
Digoxin’s Second Chance Just Ran Out: What a Failed Phase 3 RCT Reveals About Cardiovascular Drug Development
Low-dose digoxin cut hospitalizations but missed its primary endpoint in a 1,400-patient RCT—exposing a gap between statistical significance and...
Denali Launches AVLAYAH for Hunter Syndrome; DNL628 Tau Program Advances
Denali launches AVLAYAH for Hunter Syndrome following FDA accelerated approval, with confirmatory Phase 2/3 COMPASS trial required to sustain...
CytomX Dose Optimization for Varsetatug Masetecan Due H2 2026
CytomX's dose optimization for varsetatug masetecan in colorectal cancer readout expected H2 2026 will determine monotherapy selection and registrational...
Atsena’s ATSN-201 and ATSN-101 Show Durable Effects in XLRS and LCA1 Trials
Atsena's gene therapies show durable structural and functional improvements in XLRS and LCA1 trials, with safety sustained through 36...
Artiva’s AlloNK Plus Rituximab Achieves 71% Response in Refractory RA
Artiva's AlloNK Plus Rituximab achieved 71% ACR50 response in refractory RA patients with Phase 3 trial now underway.