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FDA slaps Genzyme with a refuse-to-file letter on a supplemental BLA for Lemtrada (alemtuzumab) as a treatment for relapsing multi...[ Price : $8.95]
FDA approves a Gilead Sciences NDA for Stribild, a once-a-day combination pill to treat HIV-1 infection in adults.[ Price : $8.95]
FDA lifts a clinical hold against Lpath and its iSonep, an anti-S1P monoclonal antibody that is being developed as a potential tre...[ Price : $8.95]
FDA releases a draft guidance on the self-identification requirement under generic drug user fee act.[ Price : $8.95]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]
Closing a 38-year interactive connection with rank-and-file FDA employees, FDA Webview editor Jim Dickinson says goodbye to FDA em...[ Price : $8.95]
A recent qui tam lawsuit by FDA reviewers and an insider trading case prompt a prominent lawyer to raise questions about FDAs abil...