The ranking member of a House Select Committee on competition with China writes to three Chinese drug companies asking for detailed information on the...
FDA clears a BD 510(k) for its EnCor EnCompass Breast Biopsy and Tissue Removal System, a new platform designed to allow clinicians to perform breast ...
Reuters reports exclusively that FDA medical reviewers have slowed reviews on two drugs in the new Commissioners National Priority Voucher Program due...
Jazz Pharmaceuticals sells its FDA Priority Review Voucher for $200 million to an undisclosed purchaser.
FDA clears an iotaMotion 510(k) for an expanded pediatric indication for its iotaSOFT robotic-assisted cochlear implant insertion system.
Charles River Laboratories names former FDA principal deputy commissioner Namandj N. Bumpus as senior vice president and chief scientific and innovati...
FDA sends an untitled letter to Altor BioScience, alleging that promotional Web pages for bladder cancer drug Anktiva are false or misleading and viol...
FDA and the European Medicines Agency publish their collaborative 10 guiding principles for using artificial intelligence in drug development and eval...
