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 approved Fast Track Designation for Celularity’s stem cell-derived natural killer (NK) cell therapy, CYNK-001, in the development for the treatment of acute myeloid leukemia (AML). AML is a type of blood cancer in which...
The U.S. Food and Drug Administration (FDA) has accepted Rakuten Medical’s, Inc. application for to begin clinical studies of the company’s investigational new drug (IND) for patients with advanced squamous cell carcinoma or patients with neck and head squamous cell...
In a potential development for clinical trial translations to come, the U.S. Food and Drug Administration (FDA) authorized orphan drug designation (ODD) to Nkarta’s engineered natural killer (NK) cell therapy NKX101 for the treatment of acute myeloid leukemia (AML)....
The US Food and Drug Administration’s (FDA) Division of Rheumatology has authorized the clinical development of XBiotech’s Investigational New Drug (IND) Natrunix, a candidate antibody therapy to treat rheumatological diseases. Rheumatological disease, a...
The China National Medical Products Administration (NMPA) has approved SYLVANT (siltuximab for injection) for the treatment of patients with multicentric Castleman disease (MCD), BeiGene Ltd. and EUSA Pharma Ltd today announced. MCD is known as a lymphoproliferative...
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