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European Commission approves Ipsen’s Cabometyx (cabozantinib) Tablets for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy

The European Commission has approved Ipsen's Cabometyx™ (cabozantinib) 20, 40, 60 mg tablets for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. Cabomety (cabozantinib) is the only single agent to…

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New indication approved by EMA for Yervoy (ipilimumab)

On 26 April 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Yervoy. The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG. The CHMP adopted a change to the…

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FDA grants priority review to Roche’s cancer immunotherapy TECENTRIQ (atezolizumab) for initial treatment of people with a specific type of metastatic lung cancer

Roche has announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for TECENTRIQ® (atezolizumab), in combination with Avastin® (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line)…

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