FDA posts a guidance entitled Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.
Federal Register notice: FDA corrects a 9/17 notice announcing an 11/29 public workshop entitled Pathogen Reduction Technologies for Blood Safety.
FDA approves Grifols ID Core XT molecular diagnostic test for blood group genotyping.
Bristol-Myers Squibb reports disappointing topline results from its Phase 3 CheckMate-331 study evaluating Opdivo (nivolumab) versus the current stand...
FDA clears a FibriCheck 510(k) for its smartphone application that monitors heart rhythm disorders by using an optical signal originating from a smart...
FDA grants Sutro Biopharma an orphan drug designation for STRO-001 for treating multiple myeloma.
FDAs Anesthetic and Analgesic Drug Products Advisory Committee votes 8 to 7 to recommend not approving Trevenas next-generation opioid oliceridine inj...