FDA Related News

Medical Devices

Approvable Letter for Sleep Apnea Device

FDA sends Nyxoah an approvable letter on its PMA for the Genio system, a neuromodulation device for treating obstructive sleep apnea.

Biologics

Rybrevant Beats Tagrisso in Head-to-Head Trial: J&J

Johnson & Johnson says Rybrevant outperformed AstraZenecas Tagrisso in a head-to-head study in the first-line treatment of patients with locally advan...

Medical Devices

Covidien Recalls Shiley Tracheostomy Tube

Covidien recalls its Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula due to safety concerns if a component becomes...

Medical Devices

7 QS Violations in Dexcom Inspection

FDA warns San Diego-based Dexcom about Quality System violations in its production of unapproved glucose monitors.

Human Drugs

API Deviations at Aspen Biopharma Labs

FDA warns Indias Aspen Biopharma about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Medical Devices

Smiths Medical Recalls Endotracheal Tubes

Smiths Medical recalls its oral/nasal endotracheal tubes after becoming aware that certain device sizes may have a smaller diameter than expected.

Human Drugs

Cassava Says Simufilam Failed in Alzheimers Study

Cassava Sciences reports topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate Alzheimers disease, showing that the stud...

Human Drugs

Confirmatory Evidence in Non-Oncologic Rare Diseases

FDA researchers examine the use of confirmatory evidence with one adequate and well-controlled trial in non-oncologic drug rare disease marketing appl...

Human Drugs

FDA Adds New Chief Operating Officer

FDA selects former consultant Barclay Butler as its deputy commissioner for operations and chief operating officer.

Regulate Silver Fluoride as Drug: Petition

Advantage Silver Dental Arrest asks FDA to rescind medical device approvals for silver diamine fluoride and silver fluoride agents and regulate them a...