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FDA finalizes a sweeping overhaul of the National Drug Code system, adopting a standardized 12-digit format for the identifier use...[ Price : $8.95]
FDA places a partial clinical hold on a mid-stage U.S. trial of PepGen Inc.s experimental therapy for myotonic dystrophy Type 1.[ Price : $8.95]
FDA posts the form FDA-483 with six observations from a 2023 inspection at the Fujian Genohope Biotech sterile drug manufacturing ...[ Price : $8.95]
FDA denies an Age Reversal Unity petition asking the agency to establish a framework and issue guidance for expedited clinical tri...[ Price : $8.95]
FDA warns Phoenix, AZ-based Diasol, Inc., about multiple Quality System and Medical Device Reporting violations in its illegal man...[ Price : $8.95]
FDA denies a BioMarin petition asking it not to approve any C-type natriuretic peptides to treat achondroplasia until the expirati...[ Price : $8.95]
FDA grants Vanda Pharmaceuticals a long-sought formal evidentiary public hearing to review the agencys proposal to refuse approval...[ Price : $8.95]
FDA cites Chinese active pharmaceutical ingredient manufacturer Hubei JXBio Pharmaceutical Co for multiple deficiencies in its han...