Endo is ordered to pay $1.85 billion in fines and forfeitures after pleading guilty to introducing misbranded Opana ER into interstate commerce and cl...
FDA warns Chinas Bioptimal International about multiple violations at a Singapore facility manufacturing two unapproved catheters.
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...
