FDA approves Chiesis Lamzede to treat some manifestations of alpha-mannosidosis in adults and children.
Federal Register notice: FDA withdraws a Miles Laboratories ANDA for alcohol and dextrose injection, 5 mL/100 mL because the agency has scientific dat...
FDA publishes a draft guidance with information on requesting and conducting product-specific guidance meetings between FDA and ANDA applicants.
FDA commissioner Robert Califf announces a project to explore ways the agency can respond to and counter misleading health information in a variety of...
FDA clears a Zephyrus Innovations 510(k) for its Aerojec 3ml safety syringe.
FDA approves Apellis Pharmaceuticals Syfovre to treat geographic atrophy secondary to age-related macular degeneration.
Federal Register notice: FDA makes available a final guidance on compounding certain ibuprofen oral suspension products.
Federal Register notice: FDA announces two public meetings on electronic submission of adverse event reports using International Council for Harmoniza...
