2nd Annual Clinical Affairs & Regulatory Approvals For Diagnostics, September 12-13,
Understanding Changes to FDA Regulatory Pathways and the Relative Evidentiary Requirements, Identifying Sample Size and Trial Design for Successful Submissions for Diagnostic Clinical Studies As diagnostic...
China Medical Technologies, Inc. (the "Company") (Nasdaq: CMED), a leading China-based advanced in-vitro diagnostic ("IVD") company, announced that it has received approvals for its prostate cancer FISH detection kit and Topoisomerase 2-alpha ("TOP2A") FISH detection kit from the State Food and...
Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) announced that the U.S. Food and Drug Administration (FDA), along with the European Medicines Agency (EMA) of the European Union (E.U.) and Health Canada, the Canadian Regulatory Agency, have each approved single-use, pre-filled syringes of...