The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and paraganglioma.
The trial enrolled an estimated 322 patients who received WELIREG 120 mg orally once daily. About pheochromocytoma and paraganglioma Pheochromocytoma and paraganglioma (PPGL) are rare adrenal tumors ...
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.
Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral HIF-2α inhibitor, Welireg (belzutifan), for a new indication. The sNDA is ...
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MRK's sNDA for Welireg in Rare Tumors Gets FDA's Priority TagMerck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral ...
The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...
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