YARTEMLEA
Jan 06, 2026
Zenas BioPharma’s Obexelimab Delivers Positive Phase 3 Results in IgG4-RD; Sanofi Secures US Priority Review for Tzield in Pediatric Stage 2 Type 1 Diabetes; Axsome’s AXS-05 sNDA Accepted by FDA with Priority Review for Alzheimer’s Agitation; Vanda’s NEREUS Receives FDA Approval; Omeros’ YARTEMLEA Sets Milestone as First Approved TA-TMA Therapy
Zenas BioPharma Announces Successful Phase 3 INDIGO Study of Obexelimab in IgG4-RD Zenas BioPharma has announced positive top-line results from its pivotal Phase 3 INDIGO clinical trial evaluating obexelimab for the treatment of IgG4-Related Disease (IgG4-RD). IgG4-RD is a rare, systemic, chronic fibroinflammato...
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Jan 05, 2026
FDA Approves Omeros’ YARTEMLEA: A Breakthrough for Stem Cell Transplant Patients Facing TA-TMA
The FDA has approved YARTEMLEA (narsoplimab-wuug), marking a watershed moment in hematopoietic stem cell transplantation (HSCT) medicine. Omeros Corporation's therapeutic advance represents the first and only FDA-approved treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA...
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