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FDA Approves Labeling Supplement for Puma Biotechnology’s Breast Cancer Drug Nerlynx

Puma Biotechnology Inc. announced that the U.S. Food and Drug Administration approved a labeling supplement for Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer.

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FDA approves expanded label for Regeneron/Sanofi’s Dupixent

The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals Inc. and Sanofi SA’s drug Dupixent to treat nasal polyps, marking the third major use for the injectable medicine.

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FDA approves expanded label for Praluent

The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals’ cholesterol drug Praluent as a treatment to cut the risk of heart attacks, stroke and other major cardiovascular events.

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