An FDA advisory committee votes unanimously against recommending approval of Johnson & Johnsons V-Wave heart shunt for patients with advanced heart fa...
A senior CDRH compliance official warns industry that persistent shortcomings in complaint handling, corrective actions, and medical device reporting ...
FDA approves Juno Therapeutics CAR-T therapy lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory marginal zone lymphoma.
FDA solicits proposals for the CDER Center for Clinical Trial Innovation Bayesian Statistical Analysis demonstration project.
CBER says that a common deficiency that is driving a significant share of BLA-related complete response letters is manufacturing facility inspection r...
FDA lifts a partial clinical hold on one of Vanda Pharmaceuticals key tradipitant studies, clearing the company to expand dosing in an ongoing motion-...
FDA publishes a guidance on implementing the eCopy submission program for medical devices.
FDA launches a pilot with the Center for Medicare and Medicaid Innovation to promote access to certain digital health devices covered through a new Ce...
