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

Summary by EuropaWire.eu
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 medical needs for conditions affecting fewer than 20…
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pharmaceutical-technology.compharmaceutical-technology.com

Sanofi's rilzabrutinib gains FDA orphan drug status

Sanofi's reversible BTK inhibitor rilzabrutinib has gained the US Food and Drug Administration’s (FDA) orphan drug designation.

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EuropaWire.euEuropaWire.eu

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

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 medical needs for conditions affecting fewer than 20…

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EuropaWire.eu broke the news in on Thursday, April 3, 2025.
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