RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved WELIREG ® (belzutifan), ...

Welireg's sNDA for advanced PPGL treatment is under FDA priority review, potentially becoming the first U.S. therapy for this condition. The LITESPARK-015 trial supports the sNDA with ORR and DOR data ...

Acceptance based on objective response rate data from the Phase 2 LITESPARK-015 trial evaluating WELIREG in certain patients with advanced PPGL If approved, WELIREG would be the only available therapy ...

DUBLIN — Adrenal-sparing surgery enables half of patients with multiple endocrine neoplasia type 2 (MEN2) and bilateral pheochromocytoma to gain 10 years without adrenal insufficiency yet still have a ...

Findings showed an ORR of 26% (95% CI, 17-38), with a median duration of response of 20.4 months (95% CI, 8.3, not reached). The Food and Drug Administration (FDA) has approved Welireg ™ (belzutifan) ...

The new results will help to follow patients with a bad prognosis more closely, and to move towards more personalized treatments. Mercedes Robledo, co-lead author, has been studying pheochromocytomas ...

Pheochromocytoma and paraganglioma are neoplasms originating in the adrenal medulla and extraadrenal paraganglia, respectively. Most cases of metastatic pheochromocytoma and paraganglioma are driven ...

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WELIREG is indicated for the treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). Selected Safety ...