FDA approves an Obalon Therapeutics PMA supplement for the Obalon Touch Inflation System for use in inflating the Obalon Balloon, a swallowable gas-fi...
Endo extends the stay on a suit against FDA following an agency commitment to finalize its clinical need determination for vasopressin by 12/31.
FDA releases the FDA-483 with 16 observations from an inspection at the Pharm D Solutions outsourcing facility.
Neurelis files an NDA for Valtoco (diazepam nasal spray) as a treatment for epilepsy in patients six years and older who experience increased bouts of...
FDA clears a Renovis Surgical Technologies 510(k) to market the Tesera X Lateral Interbody Fusion System.
Federal Register notice: FDA announces an 11/2 joint advisory committee meeting to review a Sage Therapeutics NDA for its proposed postpartum depressi...
Federal Register notice: FDA makes available a draft guidance entitled Good Review Management Principles and Practices for New Drug Applications and B...
Federal Register notice: FDA makes available a final guidance entitled ANDA Submissions Content and Format.