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CDCs Advisory Committee on Immunization Practices votes to discontinue the longstanding policy that all newborns receive the Hepat...[ Price : $8.95]
An FDA advisory committee votes unanimously against recommending approval of Johnson & Johnsons V-Wave heart shunt for patients wi...[ Price : $8.95]
A senior CDRH compliance official warns industry that persistent shortcomings in complaint handling, corrective actions, and medic...[ Price : $8.95]
FDA approves Juno Therapeutics CAR-T therapy lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory marginal z...[ Price : $8.95]
FDA solicits proposals for the CDER Center for Clinical Trial Innovation Bayesian Statistical Analysis demonstration project.[ Price : $8.95]
CBER says that a common deficiency that is driving a significant share of BLA-related complete response letters is manufacturing f...[ Price : $8.95]
FDA lifts a partial clinical hold on one of Vanda Pharmaceuticals key tradipitant studies, clearing the company to expand dosing i...[ Price : $8.95]
FDA publishes a guidance on implementing the eCopy submission program for medical devices.