FDA researchers look at manufacturing changes and comparability assessment of FDA-approved monoclonal antibodies and Fc-fusion products.
FDA grants I-Mab a breakthrough therapy designation for felzartamab, an investigational CD38 antibody for treating primary membranous nephropathy.
FDA says it will continue to exercise enforcement discretion for some supplements to PMAs and HDEs.
FDA approves Mercks Keytruda (pembrolizumab) for use with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract canc...
Former FDAer Steve Lynn asks what the drug industry and regulators can do working together to break the cycle of more than 20 years of the same CGMP i...
Federal Register notice: FDA selects interested industry organizations to participate in selecting nonvoting industry representatives to serve on cert...
Federal Register notice: FDA grants a special termination of the debarment of David Winne due to his cooperation with federal officials.
FDAs Cellular, Tissue, and Gene Therapies Advisory Committee supports Vertex Pharmaceuticals and CRISPR Therapeutics safety assessments on their sickl...
