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Federal Register notice: FDA withdraws the accelerated approval of Acrotech Biopharmas NDA for Marqibo (vincristine sulfate liposo...[ Price : $8.95]
FDA issues a complete response letter to Shanghai Junshi Biosciences and Coherus BioSciences on their BLA for toripalimab in combi...[ Price : $8.95]
FDA posts a final guidance entitled Electronic Submission of IND Safety Reports Technical Conformance Guide.[ Price : $8.95]
CDRH announces organizational changes that include new offices established within the Office of Product Evaluation and Quality.[ Price : $8.95]
FDA places a clinical hold on a Vertex Pharmaceuticals Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, f...[ Price : $8.95]
After 13 years at the agency, CDRH Digital Health Center of Excellence director Bakul Patel announces he will be leaving the agenc...[ Price : $8.95]
FDA sends HutchMed a complete response letter on its NDA for surufatinib, indicated for treating pancreatic and extra-pancreatic n...[ Price : $8.95]
FDA denies a Public Citizen petition calling for the disqualification of two researchers at Hennepin County Medical Center, Minnea...