FDA clears a Tosoh Bioscience 510(k) for its next-generation Automated Glycohemoglobin Analyzer for rapid HbA1c (blood sugar) testing.
FDA accepts for review a Lantheus NDA for LNTH-2501 (Gallium-68 edotreotide), a diagnostic kit for the preparation of Ga 68 edotreotide injection, ind...
Leaders of the Senate Special Committee on Aging ask executives of three group purchasing organizations a series of questions about vulnerabilities in...
New CDER director George Tidmarsh talks about hiring new reviewers, improving staff morale, and finding ways to safely speed drug approvals.
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 warns Chinas Qinjiang Kingphar Medical Material Co. about Quality System violations in its production of several medical devices.
