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FDA forms an internal task force to help sponsors develop new antibacterial drugs.[ Price : $8.95]
Astellas Pharma files an NDA for tacrolimus extended release capsules for preventing organ rejection in adult kidney and liver tra...[ Price : $8.95]
Congress passes the FDA User Fee Corrections Act of 2012, providing the agency with authority to collect and spend generic drug us...[ Price : $8.95]
FDA clears a Merit Medical Systems 510(k) to market its Merit Laureate hydrophilic guide wire after a February agency Warning Lett...[ Price : $8.95]
FDA clears a Teleflex Inc. 510(k) application for the Arrow FlexBlock continuous peripheral nerve block catheter.[ Price : $8.95]
Novartis says Phase 3 study results show that investigational drug RLX030 (serelaxin) reduced all-cause mortality in patients with...[ Price : $8.95]
Peregrine Pharmaceuticals says it discovered major discrepancies with data coming from a Phase 2 trial of bavituximab in second-li...[ Price : $8.95]
FDA says ICH guidances offered on stabilty data required for reviewing NDAs also applies to ANDAs.