Merck discontinues developing two Covid-19 vaccine candidates, V590 and V591 based on Phase 1 data showing that the immune responses were inferior to ...
FDA clears a Theranica 510(k) for its Nerivio therapeutic device for an expanded indication for acute treatment of episodic or chronic migraine in pat...
FDA accepts for priority review an Albireo Pharma NDA for odevixibat for treating pruritus in patients with progressive familial intrahepatic cholesta...
FDA approves an Aurinia Pharmaceuticals NDA for Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adu...
FDA Review posts the Federal Register notices for the week ending 1/22/2021.
FDA approves a Boston Scientific PMA for its fourth-generation Vercise Genus Deep Brain Stimulation System.
A Sidley law briefing examines HHSs unprecedented overreach during the Trump Administration, which has drawn increased interest in making FDA an indep...