[ Price : $8.95]
FDA approves an Alnylam Pharmaceuticals supplemental NDA to expand the label for Oxlumo (lumasiran).[ Price : $8.95]
In arguing for its market withdrawal, an FDA briefing document says Covis Makena is not effective and has known risks.[ Price : $8.95]
Fresenius Kabi recalls its Ivenix Infusion Systems large volume pump software due to a software design issue.[ Price : $8.95]
Yale University researchers say FDA should consider three ways to enhance the timely and robust assessment of drug safety signals ...[ Price : $8.95]
FDA clears a Boston Cell Standards 510(k) for its IHControls panel (HER2/ER/PR) for evaluating breast cancers.[ Price : $8.95]
CDER and CBER partner with the Critical Path Institute to plan for a consortium to facilitate clinical development programs for al...[ Price : $8.95]
Two FDA officials describe steps the agency is taking to harmonize its oversight of clinical trials with the HHS Common Rule on pr...[ Price : $8.95]
FDA says Bayer is making inadequate progress in a postmarket surveillance study of its Essure birth control device.