A senior FDA official sharply criticizes UniQures investigational gene therapy for Huntington's disease, calling it a failed product and casting doubt...
Ropes & Gray attorneys Joshua Oyster and Austin Laroche review in a WestLaw Today article FDAs new inspection approach for medical device manufacturer...
Bipartisan leaders of the Senate Select Committee on Aging ask CVS, Walgreens, and Walmart for additional information on their efforts to protect the ...
Harmed Americans for Reform in Medical Device Safety petitions FDA to investigate the Mayo Clinics use of a robotic mastectomy device.
FDA deputy commissioner for operations and chief operating officer Barclay Butler announces his retirement in the coming months.
FDA approves Janssen Biotechs Tecvayli (teclistamab) in combination with Darzalex Faspro (daratumumab hyaluronidase-fihj) for certain adult patients w...
A Buchanan petition asks FDA to take administrative and enforcement action against 503B outsourcing facilities that are marketing ophthalmic bevacizum...
FDA grants Hemab Therapeutics a breakthrough therapy designation for sutacimig, an experimental therapy being developed to prevent bleeding episodes i...
