The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and paraganglioma.
The FDA accepts and grants priority review to Merck's sNDA for Welireg to treat advanced pheochromocytoma and paraganglioma.
Rahway: Merck, known as MSD outside of the United States and Canada, has announced the U.S. Food and Drug Administration (FDA ...
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for ...
Rahway, New Jersey Tuesday, January 28, 2025, 10:00 Hrs [IST] ...
The FDA has accepted the application for belzutifan for advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...
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 ...