Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
ImmixBio: FDA Approval for IMX-110 to Treat Pediatric Cancer
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...
FDA Approval: Recorlev for Treatment of Cushing’s Syndrome
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...
FDA Tentative Approval: Vasopressin Injectable Therapy
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...
Lecanemab: FDA Fast Track Designation for AD Treatment
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 progressive...
FDA Approval: Adbry Treatment for Atopic Dermatitis
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...
Celularity: FDA Fast Track for CYNK-001 for Treatment of AML
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...
FDA Clearance: Royal Philip’s IVC Filter Removal Laser
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...
FDA Approval: First Injectable PrEP for HIV
The U.S. Food and Drug Administration (FDA) has given approval to start producing ViiV Healthcare’s cabotegavir, the first and only long-acting injectable pre-exposure prophylactic (PrEP) to reduce the risk of sexually acquired HIV-1. HIV-1 affects nearly 38 million...
FDA Approval: CAPLYTA to Treat Bipolar I and II Depression
Biopharmaceutical company, Intra-Cellular Therapies, has announced U.S. Food and Drug Administration (FDA) approval of CAPLYTA to treat bipolar I and bipolar II disorders. Bipolar is a mental disorder characterized by unusual mood swings, energy levels, and...
FDA Approval for Rakuten Medical’s IND for Cancer Cells
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...
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