The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and paraganglioma.
Rahway, New Jersey Tuesday, January 28, 2025, 10:00 Hrs [IST] ...
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.
Frontline therapy with belzutifan (Welireg) in combination with cabozantinib (Cabometyx ... Patients in cohort 1 received belzutifan at 120 mg orally once daily in combination with cabozantinib at 60 ...
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 ...
The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.
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