FDA announces a 6/10 Peripheral and Central Nervous System Drugs Advisory Committee meeting to vote on an Eli Lilly BLA for Alzheimers drug donanemab....
Federal Register notice: FDA makes available a draft guidance entitled REMS Logic Model: A Framework to Link Program Design With Assessment.
The House Oversight Committee puts pressure on FDA and its oversight of imported Chinese and other foreign active pharmaceutical ingredients and finis...
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 ...
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...
