FDA Approves Efgartigimod for All Adult Generalized Myasthenia Gravis Types
FDA approves efgartigimod for all adult generalized myasthenia gravis types, including seronegative patients previously excluded from treatment labels.
CDR132L’s Phase 2 Miss: What a Well-Run Negative Trial Reveals About Heart Failure Drug Development
Cardior's CDR132L cleared safety hurdles in phase 2 but missed primary cardiac structure endpoints—a rigorous negative result that reshapes...
The Brain Needs Fertilizer, Not Just a New Molecule
A Vanguard Publications Q&A with Madelyn, Neuro-Innovators.
CytomX Closes Dose Optimization for Varsetatug Masetecan, Eyes 2026 Data
CytomX closes dose optimization for varsetatug masetecan with 2H 2026 data readout expected to determine monotherapy selection and registrational...
Denali Pursues DNL593 Alone After Takeda Exit in GRN-FTD Program
Denali pursues DNL593 alone in GRN-FTD after Takeda's exit, with Phase 1/2 data expected before year-end in this genetically...
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...