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: ...

Results from Phase II studies demonstrated that rilzabrutinib showed clinically meaningful outcomes in patients with warm ...

Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicinesDesignation granted for warm autoimmune ...

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 ...

Sanofi reports amlitelimab improved lung function in asthma, with new phase 3 trials planned across its respiratory pipeline.

Sanofi said that its Rilzabrutinib treatment was granted orphan drug designation, which is used in the U.S. by the Food and Drug Administration. The designation is a status assigned to a medicine ...

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 ...

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 ...

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 ...

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 ...