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-mediated Diseases | 02/03/2026 | By News Bureau
Biocon Biologics Secures Global Rights to Hulio
The new agreement supersedes the existing collaboration agreement between Biocon Biologics and Fujifilm Kyowa Kirin Biologics (FKB) for biosimilar Adalimumab, under which Biocon Biologics only had commercialisation rights.
Immune-mediated Diseases | 23/12/2025 | By News Bureau | 136
UPLIZNA Becomes First and Only FDA-Approved Therapy for IGG4-Related Disease
The FDA granted Breakthrough Therapy Designation to UPLIZNA for the treatment of IgG4-RD, recognising the high unmet medical need in this serious condition and the medicine's potential to benefit patients.
Immune Mediated Diseases | 05/04/2025 | By Abha | 390
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