Workflow
Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren's disease, has now received Fast Track designation
JNJJ&J(JNJ) Prnewswire·2025-03-18 12:03

Sjögren's disease (SjD) is a prevalent, debilitating autoantibody disease with no FDA-approved advanced treatments   The Company is actively enrolling patients in the Phase 3 DAFFODIL study   This marks the fourth nipocalimab FDA Fast Track designation SPRING HOUSE, Pa., March 18, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted investigational nipocalimab Fast Track designation (FTD) for the treatment of adult patients with mod ...