[ Price : $8.95]
BioCryst Pharmaceuticals withdraws its IND for the antiviral nucleoside, BCX5191 after FDA expressed concerns about its preclinica...[ Price : $8.95]
Navidea Biopharmaceuticals resubmits its Lymphoseek NDA to FDA to answer agency questions about third-party cGMPs.[ Price : $8.95]
Attorney Steven Casey says the law remains unsettled on the question of who is liable for adverse reactions patients experience wh...[ Price : $8.95]
CDRH associate director for international affairs Kimberly Trautman says that medical device stakeholders worldwide have an opport...[ Price : $8.95]
FDA asks its Anti-infective Drugs Advisory Committee to comment on the efficacy and safety of Human Genome Sciences raxibacumab fo...[ Price : $8.95]
Ameridose, the sister company of troubled New England Compounding Center, recalls all unexpired products remaining in circulation ...[ Price : $8.95]
Biogen Idec plans to submit a BLA in the first half of 2013 for a long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc...[ Price : $8.95]
CDRH says it is puzzled by an increase in Class 1 medical device recalls seen over the past four years.