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supplmental new drug application (sNDA)

The US FDA has accepted Novartis’ supplemental new drug application (sNDA) and granted priority review designation to Promacta (eltrombopag) in combination with standard immunosuppressive therapy (IST) for first-line treatment of SAA more

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The US Food and Drug Administration (FDA) has accepted and granted priority review of a supplemental new drug application (sNDA) for Lynparza to be used in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer. more

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FDA approves sNDA for eltrombopag in patients with severe aplastic anaemia who have had an insufficient response to immunosuppressive therapy. more