FDA warns San Diego-based Dexcom about Quality System violations in its production of unapproved glucose monitors.
FDA warns Indias Aspen Biopharma about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Smiths Medical recalls its oral/nasal endotracheal tubes after becoming aware that certain device sizes may have a smaller diameter than expected.
Cassava Sciences reports topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate Alzheimers disease, showing that the stud...
FDA researchers examine the use of confirmatory evidence with one adequate and well-controlled trial in non-oncologic drug rare disease marketing appl...
FDA selects former consultant Barclay Butler as its deputy commissioner for operations and chief operating officer.
Advantage Silver Dental Arrest asks FDA to rescind medical device approvals for silver diamine fluoride and silver fluoride agents and regulate them a...
Axsome says its solriamfetol met the primary and secondary endpoints in the Phase 3 FOCUS trial in attention deficit hyperactivity disorder.