FDA provides information about the Urgent/11 cybersecurity vulnerability that could affect medical devices.
Endo says it is withdrawing a 2017 suit against FDA over agency enforcement discretion in permitting bulk drug compounding of vasopressin because the ...
FDA warns Lupin about CGMP violations and deviations at one of its units that are similar to those found in other Lupin facilities in India.
FDA releases its latest batch of Warning Letters that includes Lupin Limited, Shanghai Institute of Pharmaceutical Industry, Dermameal, and Galt Pharm...
Heron Therapeutics resubmits an NDA for HTX-011, an investigational agent for managing postoperative pain.
Former FDA commissioner Robert Califf accepts a full-time role at Alphabet Company as the head of medical strategy and policy for Google Health and Ve...
FDA clears a Luminex 510(k) for the Aries MRSA Assay, a real-time, polymerase chain reaction-based, in vitro diagnostic test for detecting methicillin...
FDA warns Chinas Shanghai Institute of Pharmaceutical Industry that the agency may withhold approval of ANDAs or supplements listing it as a manufactu...