FDA cites Connecticut outsourcing facility Brookfield Medical/Surgical Supplies for inadequate investigations involving 13 out-of-specification potency results.
FDA issues a strategy document summarizing discussions at a 2025 workshop on developing interchangeable biosimilar products.
FDA cites Connecticut outsourcing facility Brookfield Medical/Surgical Supplies for inadequate investigations involving 13 out-of-specification potency results.
FDA issues a strategy document summarizing discussions at a 2025 workshop on developing interchangeable biosimilar products.
A KFF Health News report documents hundreds of FDA-mandated postmarket studies whose reports are listed as delayed.
FDA approves Ultragenyx Pharmaceutical’s Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with Sanfilippo syndrome type A.
