The European Commission (EC) has granted orphan-drug designation (ODD) for Astex Pharma’s oral fixed dose ASTX727 to treat Acute Myeloid Leukemia (AML). AML, a blood cancer characterized by the overproduction of immature white blood cells within the bone marrow, is...
The U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for AlloVir’s posoleucel (Viralym-M, ALVR105) to treat adenovirus (AdV) infection following allogeneic hematopoietic stem cell transplant (allo-HCT). AdV...
Cstone Pharmaceuticals has announced the U.S. Food and Drug Administration’s (FDA) STUDY MAY PROCEED (SMP) letter and investigational new drug (IND) application approval for CS5001, a potential antibody-drug conjugate (ADC) to target receptor tyrosine kinase-like...
The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for ImmixBio’s IMX-110 for the treatment of a form of pediatric cancer in children. The cancer, rhabdomyosarcoma (RMS), is a malignant neoplasm and a very common sarcoma...
The U.S. Food and Drug Administration (FDA) has granted approval of Xeris Biopharma’s drug Recorlev (levoketoconazole) for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome. Endogenous Cushing’s syndrome is a rare, but serious and...
The U.S. Food and Drug Administration (FDA) has granted a tentative approval for Amphastar’s Abbreviated New Drug Application (ANDA) for an injectable vasopressin therapy to increase blood pressure in adults with vasodilatory shock. As part of the clinical syndrome of...
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