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News about "Immune Thrombocytopenia "
Japan Grants Orphan Drug Designation to Sanofi's Rilzabrutinib
Sanofi’s rilzabrutinib has received Orphan Drug Designation in Japan for IgG4-related disease (IgG4-RD), supported by positive phase-II study results. The decision marks the therapy’s third global orphan designation in this indication, underscoring Sanofi’s continued focus on advancing treatments for rare immune-mediated diseases.
Immune Thrombocytopenia | 02/03/2026 | By News Bureau
EU Approves Sanofi's Wayrilz as First BTK Inhibitor for Immune Thrombocytopenia
Sanofi has received EU approval for Wayrilz, the first Bruton’s Tyrosine Kinase (BTK) inhibitor indicated for immune thrombocytopenia, offering a novel multi-immune modulation approach. The approval is based on positive results from LUNA 3 study, which demonstrated rapid and durable platelet responses.
Immune Thrombocytopenia | 24/12/2025 | By News Bureau | 117
Ouro Medicines Receives US FDA ODD for Gamgertamig (OM336) for Immune Thrombocytopenia
Ouro Medicines has secured a second ODD from the FDA for gamgertamig (OM336), this time for immune thrombocytopenia (ITP), following an earlier designation for autoimmune hemolytic anemia (AIHA). It comes as the company completes dosing in the first cohort of its global basket trial in autoimmune cytopenias.
Immune Thrombocytopenia | 09/12/2025 | By Akanki | 237
CASI Pharmaceuticals Advances CID-103 into Clinical Development for Chronic Immune Thrombocytopenia
CASI received a letter from the FDA indicating clearance for the study to proceed, signaling regulatory approval for the advancement of CID-103 into clinical trials.
Immune Thrombocytopenia | 16/05/2024 | By Abha | 618
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