Federal Register notice: FDA announces that CDRH Office of Product Evaluation and Quality has modified its organizational structure.
FDA approves an AB therapeutic equivalence code for cancer drug paclitaxel suspension and tells HBT Labs it must formally apply for a return of PDUFA ...
Federal Register notice: FDA issues an order permanently debarring Adam Paul Runsdorf over his felony conviction for conspiring to distribute counterf...
CDER launches a new Quantitative Medicine Center of Excellence to help streamline and accelerate drug development.
A Phase 2b clinical study evaluating Johnson & Johnsons investigational TAR-200 monotherapy in nonmuscle-invasive bladder cancer patients with carcino...
GlycoMimetics says its Phase 3 study of uproleselan plus chemotherapy in acute myeloid leukemia patients did not achieve a statistically significant i...
FDA posts a draft guidance entitled REMS Logic Model: A Framework to Link Program Design With Assessment" to help applicants with designing and managi...
Federal Register notice: FDA withdraws approval of 12 ANDAs from multiple applicants after they notified the agency that they were no longer marketed.
