FDA approves AstraZeneca and Daiichi Sankyos Enhertu (trastuzumab deruxtecan) for treating adult patients with unresectable or metastatic hormone rece...
FDA warns the Miami Dade Medical Research Institute and Dr. Americo Padilla about failing to obtain proper informed consent for pediatric patients in ...
FDA warns New York, NY-based Evolutionary Biologics and Chatsworth, CA-based Chara Biologics about illegally manufacturing and distributing unapproved...
FDA sets 5/25 for its decision on a new indication for Mercks Welireg to treat patients with advanced pheochromocytoma and paraganglioma.
FDA clears an AI Optics 510(k) for its Sentinel Camera, a handheld retinal imaging device for capturing images of the human eye.
TerSera petitions FDA to require any ANDA referencing Prialt to conduct compatibility testing with the Medtronic pump that is specified in Prialts lab...
Robert F. Kennedy Jr.s cousin, Caroline Kennedy, sends a scathing letter about his background to U.S. senators on the eve of a confirmation hearing to...
Provepharm recalls one lot of phenylephrine hydrochloride injection, USP, 10 mg/mL due to a customer complaint about visible black particulate matter ...
