Events

Romosozumab Receives FDA Approval for Postmenopausal Osteoporosis

Drug/Device: Romosozumab - Drug

Sponsor:  Amgen Inc.

Committee: Bone, Reproductive, and Urologic Drugs Advisory Committee

Indications: Treatment of osteoporosis in postmenopausal women at high risk of fracture, defined as a ...

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Febuxostat from Takeda Receives Expanded FDA Approval

Drug/Device: Febuxostat

Sponsor: Takeda Pharmaceuticals USA

Committee:  Arthritis Advisory Committee And Drug Safety And Risk Management Advisory Committee

Indications：the second line therapy for the treatment of hyperuricemia in patients with gout who ...

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FDA Approves Optimizer Smart Device for Class III Heart Failure Patients

Drug/Device: OPTIMIZER SMART device

Sponsor: Impulse Dynamics (USA), Inc.

Committee: Medical Devices Advisory Committee

Indications：to provide cardiac contractility modulation (CCM) for class III heart failure patients who are not responding ...

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