The U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Otsuka and H. Lundbeck’s drug REXULTI for the treatment of schizophrenia in pediatric patients aged 13 to 17. Schizophrenia is a life-long serious disease that 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...
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 Fast Track designation to Eisai’s lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease (AD). Alzheimer’s disease is a serious and...
Today, LEO Pharma announced the U.S. Food and Drug Administration’s (FDA) approval for the first and only treatment to target IL-13 cytokine in adults diagnosed with moderate to severe atopic dermatitis. Atopic dermatitis (eczema) is a chronic, inflammatory, skin...
The U.S. Food and Drug Administration (FDA) has granted De Novo Clearance for Royal Philip’s IVC filter removal laser sheath, CavaClear. IVC filters are used to treat patients with deep vein thrombosis (DVT), a condition in which blood clots form in the veins of the...
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