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FDA issues a safety alert warning that patients taking Amgens Tavneos (avacopan) for a rare autoimmune condition may face a risk o...[ Price : $8.95]
Looking to modernize drug and biologic development, FDA seeks industry and public input on how to expand the use of digital health...[ Price : $8.95]
Scholar Rock resubmits its BLA for apitegromab, an investigational therapy for children and adults with Spinal Muscular Atrophy.[ Price : $8.95]
A novel off-the-shelf CAR-T cell therapy developed by researchers at Washington University School of Medicine in St. Louis receive...[ Price : $8.95]
FDA's more aggressive approach to publicizing its criticisms of drugmakers draws both praise from investors and concern across the...[ Price : $8.95]
FDA inspection records show that some generic drug manufacturers are routinely failing to carry out basic safety and quality check...[ Price : $8.95]
In a coordinated action, CBER issues four untitled letters targeting promotional materials for leading T-cell therapies and signal...[ Price : $8.95]
FDA accepts for priority review a Praxis Precision Medicines NDA for relutrigine, an investigational therapy targeting rare geneti...