FDA allows Mesoblast to submit on a rolling basis a BLA for its allogeneic cellular medicine remestemcel-L for use in children with steroid-refractory...
FDA clears a SI-Bone 510(k) for use of its iFuse Bedrock technology in fusion of the sacroiliac joint during long construct procedures.
FDA releases its latest batch of Warning Letters that includes Luen Fook Medicine and RIJ Pharmaceutical.
FDA acting commissioner Ned Sharpless says the White House and HHS want him to continue the leadership path set by former commissioner Scott Gottlieb.
CDER says its statisticians are working on adaptive clinical trial designs to make clinical evaluation of new drug treatments more efficient and infor...
A just-posted Form 483 includes nine observations from an inspection at Temple, TX-based QuVa Pharma.
Federal Register notice: FDA submits to OMB a revised information collection on Tropical Disease Priority Review Vouchers.
Federal Register notice: FDA publishes a list of nine information collections that have been approved by OMB.