Xspray seeking FDA approval for oral CML treatment XS003
Xspray Pharma has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for its oral therapy XS003 (nilotinib) for the…
Blood cancer
Blood cancer therapy SGR-2921 discontinued after patient deaths
Biotech company Schrödinger said it’s discontinuing the development of SGR-2921, an experimental therapy for certain types of blood cancer, following the deaths of…
FDA fast tracks birelentinib for certain hard-to-treat blood cancers
The U.S. Food and Drug Administration (FDA) granted fast track designation to birelentinib as a potential treatment for certain forms of blood cancer. The…
Scemblix now OK’d in Canada for treating newly diagnosed CML
More people in Canada with the rare blood cancer Ph+ CML — fully, Philadelphia chromosome-positive chronic myeloid leukemia — in the…
Aucatzyl approved in Europe for relapsed/refractory B-ALL
The European Commission has approved Autolus Therapeutics’ cell therapy Aucatzyl (obecabtagene autoleucel) as a treatment for B-cell precursor acute lymphoblastic leukemia (B-ALL), an aggressive…
AML treatment ICT01 granted FDA’s orphan drug status
ICT01, an immune-modulating therapy being developed by Imcheck Therapeutics for acute myeloid leukemia (AML), has been granted orphan drug status by the U.S. Food…
Oral Inqovi, venetoclax for acute myeloid leukemia to be reviewed
The U.S. Food and Drug Administration (FDA) has agreed to review an application for oral Inqovi (decitabine and cedazuridine) in combination with oral venetoclax for…
SENTI-202 granted FDA orphan drug designation for blood cancers
Senti Biosciences‘ experimental cell therapy SENTI-202 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) as a potential therapy…
Revuforj gets FDA priority review for AML with NPM1 mutations
U.S. regulators have granted priority review to Syndax’s application to extend the approval of Revuforj (revumenib) to treat relapsed or refractory acute myeloid leukemia (AML)…
FDA approves Brukinsa tablet for CLL, certain B-cell lymphomas
The U.S. Food and Drug Administration (FDA) has approved a tablet formulation of Beone Medicines’ Brukinsa (zanubrutinib) — previously marketed by the developer in…
