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The U.S. Department of Justice charges the former chief regulatory officer at ExThera Medical Corp. with concealing serious advers...[ Price : $8.95]
FDA grants Hemab Therapeutics a breakthrough therapy designation for sutacimig, an experimental therapy being developed to prevent...[ Price : $8.95]
Harmed Americans for Reform in Medical Device Safety petitions FDA to investigate the Mayo Clinics use of a robotic mastectomy dev...[ 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 the form FDA-483 with six observations from a 2023 inspection at the Fujian Genohope Biotech sterile drug manufacturing ...