Tag Archives: phase 2a study

FDA Grants Orphan Drug Status to Sanofi’s Rilzabrutinib: A New Hope for wAIHA, IgG4-RD, and Beyond

(IN BRIEF) Rilzabrutinib, an investigational oral BTK inhibitor, has received orphan drug designation from the FDA for treating warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD), two rare conditions with no approved treatments. This designation, aimed at addressing unmet … Read the full press release