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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]
Rep. Jake Auchincloss (D-MA) criticizes FDAs new voucher program that offers select drugmakers sharply shortened review timelines,...[ Price : $8.95]
Acting CDER director Tracy Beth Hoeg looks to hire the petitioner behind a request the Center is considering to add new Warnings t...[ Price : $8.95]
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 a complete-response letter that outlined last month's rejection of Regenxbios BLA for its gene therapy clemidsogene lanp...