FDA grants fast-track designation to Alphamab Oncologys JSKN003 to treat several cancers.
A federal court ruling finds that FDA acted unlawfully by imposing certain REMS restrictions on mifepristone.
FDA proposes a major shift in how biosimilars are evaluated, signaling that many products may no longer need traditional comparative clinical efficacy...
FDA warns Chinas Qinjiang Kingphar Medical Material Co. about Quality System violations in its production of several medical devices.
Two Hyman, Phelps & McNamara attorneys report on the optimistic tone at a recent FDA public meeting on increasing U.S. drug manufacturing.
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...
