The U.S. Department of Justice charges the former chief regulatory officer at ExThera Medical Corp. with concealing serious adverse events including ...
FDA grants Hemab Therapeutics a breakthrough therapy designation for sutacimig, an experimental therapy being developed to prevent bleeding episodes i...
Harmed Americans for Reform in Medical Device Safety petitions FDA to investigate the Mayo Clinics use of a robotic mastectomy device.
FDA finalizes a sweeping overhaul of the National Drug Code system, adopting a standardized 12-digit format for the identifier used to uniquely distin...
FDA places a partial clinical hold on a mid-stage U.S. trial of PepGen Inc.s experimental therapy for myotonic dystrophy Type 1.
Rep. Jake Auchincloss (D-MA) criticizes FDAs new voucher program that offers select drugmakers sharply shortened review timelines, arguing the program...
Acting CDER director Tracy Beth Hoeg looks to hire the petitioner behind a request the Center is considering to add new Warnings to commonly prescribe...
FDA posts the form FDA-483 with six observations from a 2023 inspection at the Fujian Genohope Biotech sterile drug manufacturing facility in Fujian, ...
