CellProthera says a recent FDA meeting led to their alignment on a planned pivotal Phase 3 trial design for its ProtheraCytes cell therapy for use in ...
Federal Register notice: FDA classifies certain digital therapy devices for attention deficit hyperactivity disorder into Class 2.
Federal Register notice: FDA announces a minor technical modification to an alternative option that permits quarterly manufacturer reporting of certai...
Federal Register notice: FDA makes available a final guidance entitled Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.
Johnson & Johnson files a BLA for nipocalimab, indicated for treating people living with generalized myasthenia gravis.
FDA publishes two revised Veterinary International Conference on Harmonization guidances on validation of analytical procedures for veterinary drugs.
FDA clears a Think Surgical 510(k) for the TMini Miniature Robotic System and its use with the GMK Sphere and SpheriKA Knee Systems from Medacta Inter...
Merck says that on the recommendation of independent data monitoring committees, it is discontinuing a Keytruda lung cancer trial and a cutaneous squa...
