A Buchanan petition asks FDA to take administrative and enforcement action against 503B outsourcing facilities that are marketing ophthalmic bevacizum...
Bipartisan leaders of the Senate Select Committee on Aging ask CVS, Walgreens, and Walmart for additional information on their efforts to protect the ...
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 finalizes a sweeping overhaul of the National Drug Code system, adopting a standardized 12-digit format for the identifier used to uniquely distin...
