DA releases a 39-page FDA-483 with 13 observations issued following a lengthy inspection at Lupins Somerset, NJ, drug manufacturing facility.
FDA grants accelerated approval to Janssen Biotechs Darzalex Faspro (daratumumab plus hyaluronidase) for combination use with bortezomib, cyclophospha...
FDA approves a Daiichi Sankyo BLA for Enhertu (fam-trastuzumab deruxtecan-nxki) for certain adult patients with locally advanced or metastatic HER2-po...
FDA clears a DePuy Synthes 510(k) for the Velys Robotic-Assisted Solution and its use with the Attune Total Knee System.
FDA releases its latest batch of Warning Letters that includes one medical product company Bodyhealth.
U.S. Stem Cell tells an appeals court that its stromal vascular fraction procedure is not subject to FDA regulation under a 2001 FDA rule.
FDA accepts for priority review an Omeros BLA for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy.
FDA gives PMA approval to Seno Medical Instruments Imagio diagnostic breast cancer imaging technology.