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Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482)


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Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482)
Application Based on Objective Response Rate From Phase 2 Trial Evaluating Belzutifan in Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma
New Filing Further Strengthens Merck’s Expanding and Diverse Oncology Portfolio
KENILWORTH, N.J. (BUSINESS WIRE) Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a New Drug Application (NDA) for the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor belzutifan (pronounced bell-ZOO-ti-fan), a novel investigational candidate in Merck’s oncology pipeline, for the potential treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC), not requiring immediate surgery. This NDA is based on data from ....

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Merck Receives Priority Review From FDA for New Drug Application for HIF-2? Inhibitor Belzutifan


Merck Receives Priority Review From FDA for New Drug Application for HIF-2? Inhibitor Belzutifan
Application Based on Objective Response Rate From Phase 2 Trial Evaluating Belzutifan in Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma New Filing Further Strengthens Merck’s Expanding and Diverse Oncology Portfolio Merck known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has accepted and granted priority review for a New Drug …
Application Based on Objective Response Rate From Phase 2 Trial Evaluating Belzutifan in Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma
New Filing Further Strengthens Merck’s Expanding and Diverse Oncology Portfolio ....

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