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 FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and paraganglioma.
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...
The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.
Rahway: Merck, known as MSD outside of the United States and Canada, has announced the U.S. Food and Drug Administration (FDA ...
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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 ...
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 ...
Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its Welireg oral cancer drug ... around the adrenal glands. The Rahway, N.J ...
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for ...
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