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Federal Register notice: FDA corrects a 6/2 notice wrongly announcing that Tomers ANDA for calcipotriene was being withdrawn.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.
VistaPharm (Largo, FL) recalls one lot of sucralfate oral suspension due to Bacillus cereus contamination.
FDA issues Coherus BioSciences a complete response letter on its BLA supplement for Udenyca Onbody, the companys on-body injector presentation of Uden...
After suffering severe tornado damage at its Rocky Mount, NC plant, Pfizer says it has now restarted most manufacturing lines.
