FDA approves a W. L. Gore expanded indication for its Gore Cardioform Septal Occluder for patent foramen ovale (PFO) closure to prevent recurrent isch...
FDA orders its first-ever mandatory recall for contaminated food products containing kratom manufactured by Triangle Pharmaceuticals.
Drug companies ask the Supreme Court to determine whether consumers who say they lost money on prescription eye drops because the bottles dispense dru...
Federal Register notice: FDA withdraws approval of five NDAs because the drug products are no longer marketed.
Stakeholders express appreciation for FDA public sessions on implementing the Drug Supply Chain Security Act and offer suggestions for improvements.
FDA approves an AstraZeneca NDA for Bydureon (exenatide extended-release) for injectable suspension as an add-on therapy to basal insulin in adults wi...
Industria Farmacutica Andrmaco (Toluca, Mexico) recalls topical drug product Pasta De Lassar Andromaco zinc oxide diaper rash treatment after an FDA l...
Stakeholders ask FDA for changes to a draft guidance on CLIA and 510(k) waivers.