The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.
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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 FDA has accepted the application for belzutifan for advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
Priority review for Welireg is based on data from the Phase II LITESPARK-015 trial, which showed promising response rates in patients with advanced, unresectable, or metastatic pheochromocytoma and ...
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