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Federal Register notice: FDA corrects a 12/18 notice that announced the withdrawal of a Chartwell RX Sciences NDA for Flowtuss.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled E2D(R1) Post-Approval Safety Data: Definitions and Standard...[ Price : $8.95]
A Science investigative report looks at issues found by FDA in a laboratory analysis of results from trials of Cassavas potential ...[ Price : $8.95]
Republican Sen. Bill Cassidy asks interested parties to submit their ideas for congressional action to reform the regulation of cl...[ Price : $8.95]
FDA approves a Madrigal Pharmaceuticals NDA for Rezdiffra (resmetirom) for treating adults with noncirrhotic non-alcoholic steatoh...[ Price : $8.95]
FDA publishes a draft ICH guidance on post-marketing individual case study reporting.[ Price : $8.95]
FDA medical reviewers ask the Oncology Drug Advisory Committee to weigh the benefits of the benefits and serious risks of Gerons i...[ Price : $8.95]
FDA asks the Oncologic Drugs Advisory Committee to evaluate the higher risk of early deaths in trials supporting sBLAs for Celgene...