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Pharmaceutical Technology on MSN16d
FDA awards ODD status to Sanofi’s rilzabrutinib for two rare conditionsSanofi's reversible BTK inhibitor rilzabrutinib has gained the US Food and Drug Administration’s (FDA) orphan drug designation.
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 ...
Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia Paris, April 3, 2025. The US Food and Drug Administration (FDA) has granted ...
Sanofi SNY announced that the FDA has granted orphan drug designation to its investigational BTK inhibitor, rilzabrutinib, for the treatment of warm autoimmune hemolytic anemia (wAIHA) and IgG4 ...
Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicinesDesignation granted for warm autoimmune ...
The FDA has granted orphan drug designation to rilzabrutinib for IgG4-related disease and warm autoimmune hemolytic anemia, according to a press release from the manufacturer. There are currently ...
Zacks.com on MSN17d
SNY's Rilzabrutinib Gets FDA's Orphan Drug Tag for Two Rare DiseasesThe FDA bestows an orphan drug designation to Sanofi's rilzabrutinib for treating warm autoimmune hemolytic anemia and IgG4-related disease.
Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines Designation granted for warm autoimmune hemolytic anemia and IgG4-related disease ...
Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia Paris, April 3, 2025. The US Food and Drug Administration (FDA) has granted ...
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