Events

FDA Votes to Approve Janssen Pharma’s Esketamine Drug

Drug/Device: Drug-device combination

Sponsor: Janssen Pharmaceuticals, Inc.

Committee: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM)

Indications: a drug-device combination of ...

Find out more »

FDA Discusses Benefit Risk Profile of Transvaginal Mesh

Drug/Device: Device, transvaginal surgical mesh (Uphold LITE, Xenform, Restorelle DirectFix Anterior, and Pelvic Floor Repair Matrix)

Sponsors/manufacturers: Boston Scientific, Coloplast, and Acell Matristem

Committee: Medical Devices Advisory Committee – Obstetrics and Genecology Device ...

Find out more »

Sotagliflozin Receives Split FDA Vote

Drug/Device: Sotagliflozin - Drug

Sponsor:  Sanofi Aventis, U.S., LLS

Committee:  Endocrinologic and Metabolic Drugs Advisory Committee

Indications：an adjunct to insulin in adult patients with type 1 diabetes

Question 1: Does ...

Find out more »