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 ...
The 2004 WHO classification of endocrine tumors defines pheochromocytoma as a tumor arising from catecholamine-producing chromaffin cells in the adrenal ... paraganglioma. Closely related tumors ...
The FDA has accepted the application for belzutifan for advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...
“Pheochromocytoma and paraganglioma are rare tumors that form in and around the adrenal glands, and currently, there are no approved therapies available in the US for patients with this rare ...
The presented patient had recurrent pheochromocytomas, in addition to a nonfunctioning incidentaloma; his mother has a history of multiple HNPs. Familial involvement and multiple tumors within a ...
The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.
Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its Welireg oral cancer drug in patients with rare tumors that form in and around the ...
“Pheochromocytoma and paraganglioma are rare tumours that form in and around the adrenal glands, and currently, there are no approved therapies available in the US for patients with this rare disease, ...
The Rahway, N.J., drugmaker on Monday said the application covers Welireg for patients 12 years and older with advanced, unresectable or metastatic pheochromocytoma and paraganglioma. The FDA ...