Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral ...
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...
The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...
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 supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.
Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.
The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to include its use for the treatment of the rare cancer pheochromocytoma ...
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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