Viatris plans to submit an NDA later this year for phentolamine ophthalmic solution 0.75% for treating presbyopia based on just-released data from a P...
FDA grants Syndax Pharmaceuticals a priority review of its supplemental NDA for Revuforj (revumenib) as a treatment for relapsed or refractory acute m...
Former GOP Rep. John Doolittle calls for immediate steps to reverse some of the FDA restructuring that he says will hurt regulated companies, patients...
FDA approves an InspireMD PMA for its CGuard Prime Carotid Stent System for treating carotid artery stenosis.
Cook Medical recalls its Beacon Tip 5.0 Fr Angiographic Catheter because it may experience tip separation.
FDA warns Sterling Distributors about its multiple violations of the Drug Supply Chain Security Act.
FDA posts a final guidance entitled Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment.
FDA approves an updated label for Eli Lillys Amyvid (florbetapir F 18 injection) for brain imaging to estimate amyloid plaque density in patients bein...
