News
The table below is a review of notable updates that occurred in March 2025 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.
FDA Grants Orphan Drug Designation to Sanofi’s Rare Disease Drug Rilzabrutinib for wAIHA & IgG4-RD
Results from Phase II studies demonstrated that rilzabrutinib showed clinically meaningful outcomes in patients with warm ...
Uplizna is the first approved treatment for immunoglobulin G4-related disease (IgG4-RD), a chronic inflammatory condition ...
Kye Pharmaceuticals, Inc. ("Kye") announced today it has submitted a New Drug Submission (NDS) to Health Canada for the regulatory review and approval of AGAMREE® (vamorolone). If approved, AGAMREE® ...
Biologic therapy was associated with more than seven times greater odds of reaching sustained remission compared with ...
Among patients with systemic autoimmune rheumatic diseases, hospitalization due to COVID-19 was more than twice as likely in ...
Long-term glucocorticoid (GC) use among older adults with late-onset rheumatoid arthritis (LORA) remains prevalent, despite its known adverse effects, according to study results published in ACR Open ...
The FDA approved Amgen ’s anti-CD19 therapy Uplizna Thursday for use in patients with IgG4-related disease. Uplizna is the ...
Inebilizumab-cdon (Uplizna; Amgen) was approved as the first and only treatment for immunoglobulin G4–related disease ...
FDA Grants Orphan Drug Status to Sanofi’s Rilzabrutinib: A New Hope for wAIHA, IgG4-RD, and Beyond
Rilzabrutinib, an investigational oral BTK inhibitor, has received orphan drug designation from the FDA for treating warm autoimmune hemolytic an ...
The FDA bestows an orphan drug designation to Sanofi's rilzabrutinib for treating warm autoimmune hemolytic anemia and ...
Paris: Sanofi has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to ...
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