U.S. Food and Drug Administration (FDA)

February 4, 2020February 4, 2020

CAR T-cell Therapy KTE-X19 Under Review in Europe and US for Mantle Cell Lymphoma

News

The European Medicines Agency (EMA) has validated and is now reviewing Kite Pharma’s application requesting the approval of its investigational chimeric antigen receptor (CAR) T-cell therapy KTE-X19 for adult patients with relapsed or ... Read more

August 24, 2017August 24, 2017

Syros Therapy SY-1425 Wins FDA’s Orphan Drug Designation to Treat Acute Myeloid Leukemia

News

The U.S. Food and Drug Administration (FDA) has granted orphan drug status to SY-1425 to treat acute myeloid leukemia (AML), said the drug’s developer, Syros Pharmaceuticals. The therapy is being tested ... Read more