FDA warns Chinas Contec Medical Systems about Quality System and Medical Device Reporting violations in its manufacturing of several medical devices.
FDA Office of Therapeutic Biologics and Biosimilars director Sarah Yim says the agency is focused on making biosimilar development faster and more pre...
FDA accepts for priority review a BioMarin Pharmaceutical supplemental BLA for Palynziq (pegvaliase-pqpz) to expand the therapys use for treating adol...
A Friends of Cancer Research working group white paper makes the case for seamless clinical trials for rare cancers.
FDA warns Chinas Qinjiang Kingphar Medical Material Co. about Quality System violations in its production of several medical devices.
FDA grants Revolution Medicines an orphan drug designation for its investigational therapy daraxonrasib for treating pancreatic cancer.
FDA sends Regeneron a complete response letter for its pre-filled Eylea HD syringe supplemental BLA, citing unresolved inspection findings at third-pa...
FDA warns Royal Philips, based in the Netherlands, about multiple violations at two of its U.S. medical device manufacturing facilities and one in the...
