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FDA researchers look at manufacturing changes and comparability assessment of FDA-approved monoclonal antibodies and Fc-fusion pro...[ Price : $8.95]
FDA grants I-Mab a breakthrough therapy designation for felzartamab, an investigational CD38 antibody for treating primary membran...[ Price : $8.95]
Republican members of the House Energy and Commerce Committee express concern about FDA inaction on the safety of agency laborator...[ Price : $8.95]
A transition to an improved manufacturing process leads to an FDA partial clinical hold on a Nurix Therapeutics clinical study eva...[ Price : $8.95]
Federal Register notice: FDA renews its Patient Engagement Advisory Committee for an additional two years beyond the charter expir...[ Price : $8.95]
FDA says it will continue to exercise enforcement discretion for some supplements to PMAs and HDEs.[ Price : $8.95]
FDA approves Mercks Keytruda (pembrolizumab) for use with gemcitabine and cisplatin for locally advanced unresectable or metastati...[ Price : $8.95]
Former FDAer Steve Lynn asks what the drug industry and regulators can do working together to break the cycle of more than 20 year...