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CDRH asks for public comments on several questions to help it advance the development of digital health technologies for use in di...[ Price : $8.95]
FDA approves Abbotts Alinity m molecular human papillomavirus (HPV) diagnostic test.[ Price : $8.95]
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]
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...[ Price : $8.95]
Federal Register notice: FDA selects interested industry organizations to participate in selecting nonvoting industry representati...