FDA clears a Philips 510(k) for its new Spectral CT Verida system, which the company describes as the first AI-powered detector-based spectral CT scanner.
FDA posts a draft guidance outlining how drugmakers should establish impurity specifications for antibiotics produced by fermentation and semi-synthetic processes.
FDA clears a Philips 510(k) for its new Spectral CT Verida system, which the company describes as the first AI-powered detector-based spectral CT scanner.
FDA posts a draft guidance outlining how drugmakers should establish impurity specifications for antibiotics produced by fermentation and semi-synthetic processes.
FDA issues a draft guidance outlining a proposed compliance policy that could ease certain premarket requirements for respirators already approved by National Institute for Occupational Safety and Health, signaling a shift toward reduced regulatory burden for widely used protective devices.
FDA has granted Opna Bio a fast track designation for its investigational therapy OPN-6602 and its use in treating patients with relapsed or refractory multiple myeloma who have undergone at least four prior lines of therapy.
