Events

This second submission should provide support that demonstrates no meaningful clinical difference between CT-P10 and US-licensed Rituxan.

The first submission of this biosimilar product was in April 2017 and the submission was rejected. This second submission should provide support that demonstrates no meaningful clinical difference between CT-P10 and US-licensed Rituxan.

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Elevair Endobronchial Coil System Rejected by FDA

Committee: The Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee

Indication: bronchoscopic placement of ELEVAIR Coils in patients with severe emphysema (homogeneous and/or heterogeneous) and severe ...

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Endovascular treatment of patients with infrarenal abdominal aortic aneurysms with relevant characteristics.

Committee: Circulatory Devices Panel of the Medical Devices Advisory Committee

Indication: Endovascular treatment of patients with infrarenal abdominal aortic aneurysms with relevant characteristics.

Drug/Device: AAA Stent Graft System

Sponsor: INCRAFT®

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