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CDER Office of New Drugs Director John Jenkins tells an industry audience that emerging sponsors are wreaking havoc on review acti...[ Price : $8.95]
An FDA advisory committee votes that the benefits of Janssen Pharmaceuticals Ortho Evra (norelgestromin/ethinyl estradiol transder...[ Price : $8.95]
Federal Register Final rule: FDA approves an Elanco sNADA for using tilmicosin for controlling bovine respiratory disease in group...[ Price : $8.95]
Federal Register Notice: FDA publishes a list of members that may be named to its Senior Executive Performance Review Board.[ Price : $8.95]
Dako and Genentech sign an agreement to collaborate on regulatory submissions to FDA for Dakos companion diagnostics for a Genente...[ Price : $8.95]
FDA defends a two-month extension in PDUFA submission review times under a proposed agreement reauthorizing the user fee program.[ Price : $8.95]
Sunesis Pharmaceuticals says it is continuing a Phase 3 trial of vosaroxin in acute myeloid leukemia patients after receiving a f...[ Price : $8.95]
Sen. Dan Coats (R-IN) introduces a bill to clarify and reform FDA's mission in order to keep jobs from going overseas.