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FDA approves Novartis Itvisma (onasemnogene abeparvovec-brve), a new formulation of a gene therapy for a broader age of spinal mus...[ Price : $8.95]
FDA issues a draft guidance with recommendations to help master file holders determine to which Center to submit cross-Center mast...[ Price : $8.95]
National Center for Health Research president Diana Zuckerman defends FDA advisory committees, saying they do a more thorough job ...[ Price : $8.95]
Novo Nordisk reports favorable Phase 2 data for its investigational dual-action obesity and diabetes drug amycretin, showing signi...[ Price : $8.95]
A new study of FDA advisory committee meetings reveals that a substantial portion of public speakers support drug approval, and ma...[ Price : $8.95]
FDA releases the form FDA-483 with six observations from an inspection at the Catalent Indiana sterile drug manufacturing facility...[ Price : $8.95]
FDA cites PharmaTher over alleged misleading promotional claims for its generic ketamine.[ Price : $8.95]
Novo Nordisk says data from two global Phase 3 trials of semaglutide (Ozempic and Wegovy) have failed to slow clinical progression...