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Foley Hoag attorneys analyze the questions about promotional labeling raised by a recent FDA draft guidance on prescription drug use related software.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Federal Register notice: FDA corrects a 6/2 notice wrongly announcing that Tomers ANDA for calcipotriene was being withdrawn.
FDA clears a Profound Medical 510(k) for the companys Thermal Boost module for use in conjunction with its Tulsa-Pro, which permits surgeons to ablate...
FDA clears an Exactech 510(k) for its Activit-E polyethylene for the Vantage Total Ankle System.
