Sen. Cory Booker and eight others in a bipartisan coalition reintroduce legislation to force FDA to implement the FDA Modernization Act that Congress ...
Robert F. Kennedy Jr. faces heated questioning during his confirmation hearing for his stances on vaccines, abortion rights, and conflicts of interest...
FDA accepts for review an Alvotech and Teva Pharmaceuticals BLA for AVT05, a proposed biosimilar to Janssen Biotechs Simponi and Simponi Aria (golimum...
FDA approves a new indication for Novo Nordisks Ozempic to reduce the risk of worsening kidney disease and cardiovascular death in adults with Type 2 ...
FDA grants Beckman Coulter Diagnostics a breakthrough device designation for its Access p‑Tau217/β-Amyloid 1-42 plasma ratio assay to help ...
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...
