FDA warns Mexicos Betone SA de CV about CGMP violations in its manufacturing of finished drugs.
FDA warns San Diego, CA-based Agena Bioscience about multiple violations in its manufacturing of a colon diagnostic panel as part of its MassARRAY4 sy...
FDA warns Beckman Coulter about QS regulation violations at its Chaska, MN, manufacturing facility.
FDA posts 20 potential signals of serious risks/new safety information from the fourth quarter of 2023.
Rep. David Schweikert introduces legislation to require HHS to approve a fast-track designation for treatments for addictive substances and give the t...
FDA makes available a draft guidance entitled Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.
Gritstone Bio reports mixed data from an ongoing Phase 2 portion of a Phase 2/3 study evaluating Granite, a personalized neoantigen cancer vaccine for...
Eli Lilly says any revision of an FDA guidance on weight management drugs should incorporate a modern scientific characterization of obesity as a chro...
