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CDER director Janet Woodcock tells an FDA workshop she has never liked the emphasis on surrogate endpoints in clinical trials, and...[ Price : $8.95]
Pfizer agrees to pay $14.5 million to settle a whistleblower lawsuit alleging improper marketing of Detrol and Detrol LA.[ Price : $8.95]
FDA accepts for review a Neoprobe NDA for Lymphoseek (tilmanocept) for use in intraoperative lymphatic mapping.[ Price : $8.95]
A new FDA drug safety alert warns about a potential drug interaction between Zyvox or methylene blue and serotonergic psychiatric ...[ Price : $8.95]
FDA approves a label update for Janssen Therapeutics' Prezista (darunavir) tablets to include 192-week data from the company's ART...[ Price : $8.95]
Public Citizen reiterates its call for FDA to not approve Avid Pharmaceuticals experimental imaging dye florbetapir for use in dia...[ Price : $8.95]
CDRH announces additional steps it is taking in the pre-market process to promote medical device manufacturer success through inno...[ Price : $8.95]
FDA extends by three months its review of a Biogen Idec and Elan supplemental BLA for multiple sclerosis and Crohn's disease thera...