FDA publishes an updated Global Unique Device Identification Database guidance.
FDA approves Hikmas liraglutide injection, the first generic form of Novo Nordisks Victoza it has approved.
FDA approves an expanded indication for Rhythms Imcivree to include pediatric patients as young as age 2.
FDA approves Ionis Tryngolza as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome.
FDA says it has completed its evaluation of several adverse effects found in dogs treated with Librela for pain associated with osteoarthritis.
FDA warns Indias Bhargava Phytolab about CGMP issues in its manufacturing of finished drugs and active pharmaceutical ingredients.
FDA warns Greeces Rontis Hellas about Quality System and Medical Device Reporting violations in its production of a balloon catheter.
FDA approves Bristol Myers Squibbs Opdivo Qvantig subcutaneous injection for several cancer indications.
