Attorney Maarika Kimbrell discusses the challenges facing CBER as it reorganizes to meet PDUFA 7 commitments and an increase in INDs and BLAs submitte...
FDA grants Ideaya Biosciences a Fast Track designation for IDE161 for treating certain adult patients having advanced or metastatic ovarian cancer wit...
Ionis Pharmaceuticals says it will file an NDA early next year after reporting Phase 3 topline results of olezarsen in people with familial chylomicro...
FDA clears a Trax Surgical 510(k) to market its Trax Compression Screw System that offers a wide range of bone screws for osteotomy, fixation, fusion,...
Foley Hoag attorneys analyze the questions about promotional labeling raised by a recent FDA draft guidance on prescription drug use related software.
Novartis says the Phase 3 NETTER-2 trial met its primary endpoint of improvement in progression-free survival and the key secondary endpoint of object...
FDA reviewers say clinical data submitted in a BrainStorm Cell Therapeutics BLA for Lou Gehrigs Disease treatment NurOwn do not demonstrate efficacy a...
Federal Register notice: FDA corrects a 6/2 notice wrongly announcing that Tomers ANDA for calcipotriene was being withdrawn.
