A senior FDA official sharply criticizes UniQures investigational gene therapy for Huntington's disease, calling it a failed product and casting doubt...
FDA approves Janssen Biotechs Tecvayli (teclistamab) in combination with Darzalex Faspro (daratumumab hyaluronidase-fihj) for certain adult patients w...
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 places a partial clinical hold on a mid-stage U.S. trial of PepGen Inc.s experimental therapy for myotonic dystrophy Type 1.
FDA finalizes a sweeping overhaul of the National Drug Code system, adopting a standardized 12-digit format for the identifier used to uniquely distin...
Rep. Jake Auchincloss (D-MA) criticizes FDAs new voucher program that offers select drugmakers sharply shortened review timelines, arguing the program...
