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The FDA has added 3 months to the review period for a supplemental new drug application for ruxolitinib for the treatment of patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids, making the new action date May 24, 2019.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for first-line treatment with pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel in patients with metastatic squamous non–small cell lung cancer.