Sanofi's oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor rilzabrutinib has gained US Food and Drug Administration (FDA) orphan drug designation (ODD) to treat two rare conditions: ...

Sanofi has not had the success it was hoping for with its oral BTK inhibitors, acquired as part of its $3.7 billion buyout of Principia Biopharma, but can now point to a win for rilzabrutinib in ...

Sanofi (NASDAQ:SNY) announced Tuesday that rilzabrutinib, an oral therapy for an autoimmune blood disorder called immune thrombocytopenia (ITP), reached the primary endpoint in a Phase 3 trial.

Rilzabrutinib (Sanofi) is a novel , oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor that is currently under regulatory review in the United States, European Union and China for ...

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Results from Phase II studies demonstrated that rilzabrutinib showed clinically meaningful outcomes in patients with warm autoimmune hemolytic anemia and IgG4-related disease. The FDA has granted ...

The FDA granted Sanofi (SNY) US Services’ rilzabrutinib orphan designation as a treatment of immunoglobulin G4-related disease, according to a post to the agency’s website. Don't Miss Our End ...

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 ...

With the application of Sanofi's TAILORED COVALENCY ® technology, rilzabrutinib can selectively inhibit the BTK target while potentially reducing the risk of off-target side effects. Based on its ...

Sanofi's oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor rilzabrutinib has gained US Food and Drug Administration (FDA) orphan drug designation (ODD) to treat two rare conditions ...