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...
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 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 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...
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...
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