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
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
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 | 536
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