The FDA has sent an untitled letter to R3 Stem Cell, LLC of Scottsdale, Arizona for marketing unapproved stem cell products to treat a variety of diseases and conditions.
The FDA has approved the use of Vraylar (cariprazine; Allergan) to treat depressive episodes associated with bipolar I disorder (bipolar depression) in adults.
The FDA has approved a revised product label for Octaplas (Octapharma), Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion.
The FDA has expanded the indication of Gattex (teduglutide; Shire) for injection in pediatric patients ≥1 year of age with Short Bowel Syndrome who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support).
