Approval of the nonsteroidal mineralocorticoid receptor antagonist provides the first new treatment option in over 30 years for kidney disease in adults with type 1 diabetes.

Phase 3 CELESTIMO study demonstrates significant progression free survival benefit for an mosunetuzumab combination regimen ...

Results from the final ORIGIN 3 analysis reveal that atacicept over 104 weeks significantly reduced the risk of a composite kidney disease progression event by 76% in adults with primary IgA ...

The sNDA approval provides clinicians with the first FDA-cleared photodynamic therapy for skin cancer, backed by phase 3 trial data demonstrating superior clinical and histologic clearance.

Phase 3 COVER DFUS II trial data show the autologous therapy plus standard of care significantly improves wound closure rates at 12 weeks.

Labeling update reduces required post-infusion monitoring time for initial doses from 22 to 24 hours to 6 to 8 hours in patients with extensive-stage small cell lung cancer.

SAMA and SABA + SAMA use associated with increased risk for heart failure, arrhythmia, and mortality versus no use ...

Approvals for spinal muscular atrophy and chronic kidney disease; Joenja gains expanded approval in APDS; LSD derivative earns Breakthrough status to treat major depressive disorder; and zasocitinib ...

Biweekly enzyme replacement therapy demonstrates efficacy in pediatric and adult hypophosphatasia while offering lower injection frequency.

In the phase 3 LUNA trial, atogepant demonstrated a significant reduction in migraine days during the perimenstrual period compared with placebo.