A Healthcare IT News analysis says the medical device industry and FDA are moving in the right direction to improve medical device security.
FDA commissioner Scott Gottlieb announces a 9/17 workshop on microbiome-based products and their use in preventing, treating, and curing diseases in h...
CDER says FY 2019 User Fee Program Fee invoices were emailed 8/15 with a 10/1 due date for the $309,915 fee.
A Center for Science and Democracy survey of FDA scientists praises agency leaders while raising some concerns about political and industry interferen...
FDA accepts for review an Evoke Pharma 505(b)(2) NDA for Gimoti, a nasal spray product candidate for relieving symptoms in adult women with acute and ...
FDA approves Sun Pharmaceutical Industries Cequa (cyclosporine ophthalmic solution) 0.09%, indicated to increase tear production in patients with kera...
Endo resumes its suit challenging FDAs interim policy on drug compounding and seeking removal of vasopressin from Category 1 nominations for bulk comp...
FDA approves Eisai and Mercks kinase inhibitor Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinom...