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A recent qui tam lawsuit by FDA reviewers and an insider trading case prompt a prominent lawyer to raise questions about FDAs abil...[ Price : $8.95]
FDA approves a Mallinckrodt supplemental NDA for a 32 mg tablet strength of Exalgo (hydromorphone HCI) extended-release tablets fo...[ Price : $8.95]
FDA places a clinical hold on Idenix Pharmaceuticals investigational nucleotide polymerase inhibitor IDX19368 that is being develo...[ Price : $8.95]
DePuy Orthopedics recalls all unused custom implants as part of its efforts to remediate FDA GMP and quality system issues raised ...[ Price : $8.95]
FDA reviewers say they are considering whether an additional clinical study is needed before approving an Abbott supplemental BLA ...[ Price : $8.95]
FDA approves a Medtronic PMA for its Arctic Front Advance Cardiac Cryoballoon for treating paroxysmal atrial fibrillation.[ Price : $8.95]
Eli Lilly says the cognitive and functional primary endpoints were not met in two Phase 3studies evaluating solanezumab in patient...[ Price : $8.95]
A new FDA-planned research study could lead to a more relaxed approach for using the components of drug efficacy composite scores ...