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FDA clears a Tosoh Bioscience 510(k) for its next-generation Automated Glycohemoglobin Analyzer for rapid HbA1c (blood sugar) test...[ Price : $8.95]
FDA accepts for review a Lantheus NDA for LNTH-2501 (Gallium-68 edotreotide), a diagnostic kit for the preparation of Ga 68 edotre...[ 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.