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...
FDA reportedly is exploring ways PDUFA fees can be adjusted to incentivize companies to hold clinical trials in the U.S. rather than overseas.
The Sedgwick third-quarter recall index sees a sharp increase in the number of affected drug and medical device units.
