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FDA proposes a major shift in how biosimilars are evaluated, signaling that many products may no longer need traditional comparati...[ Price : $8.95]
Two Hyman, Phelps & McNamara attorneys report on the optimistic tone at a recent FDA public meeting on increasing U.S. drug manufa...[ Price : $8.95]
FDA warns Chinas Contec Medical Systems about Quality System and Medical Device Reporting violations in its manufacturing of sever...[ Price : $8.95]
FDA Office of Therapeutic Biologics and Biosimilars director Sarah Yim says the agency is focused on making biosimilar development...[ Price : $8.95]
FDA accepts for priority review a BioMarin Pharmaceutical supplemental BLA for Palynziq (pegvaliase-pqpz) to expand the therapys u...[ Price : $8.95]
A Friends of Cancer Research working group white paper makes the case for seamless clinical trials for rare cancers.[ Price : $8.95]
FDA grants Revolution Medicines an orphan drug designation for its investigational therapy daraxonrasib for treating pancreatic ca...