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.
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...
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.
