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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...[ Price : $8.95]
Federal Register notice: FDA grants a special termination of the debarment of David Winne due to his cooperation with federal offi...[ Price : $8.95]
FDAs Cellular, Tissue, and Gene Therapies Advisory Committee supports Vertex Pharmaceuticals and CRISPR Therapeutics safety assess...[ Price : $8.95]
An FDA post reviews 50 years of agency involvement in cannabis research and predicts the increase seen in recent years will contin...