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.
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MSD wins FDA priority review for Welireg in rare endocrine cancerThe regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription ...
Currently, there are no approved therapies for PPGL in the United States. 1 “Pheochromocytoma and paraganglioma are rare tumors that form in and around the adrenal glands, and currently, there are no ...
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.
The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for ...
Rahway: Merck, known as MSD outside of the United States and Canada, has announced the U.S. Food and Drug Administration (FDA ...
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 ...
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 ...
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