The House Energy and Commerce Committee announces a 5/22 hearing titled Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices, which wil...
FDA approves Geneoscopys colorectal cancer stool-based screening test ColoSense for those aged 45 years and older with an average risk for developing ...
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Federal Register notice: FDA makes available a draft guidance entitled REMS Logic Model: A Framework to Link Program Design With Assessment.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...
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FDA posts a draft guidance entitled REMS Logic Model: A Framework to Link Program Design With Assessment" to help applicants with designing and managi...
