FDA grants Dewpoint Therapeutics an orphan drug designation for DPTX3186 and its use in potentially treating gastric cancer.
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.
