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.

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 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 FDA has accepted Merck's (NYSE:MRK) supplemental New Drug Application with priority review for its drug Welireg, also known as belzutifan, for the treatment of a rare type of adrenal gland tumors.

The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription ...

The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.

Merck & Co (NYSE:MRK) said on Monday that the U.S. Food and Drug Administration (FDA) has granted priority review to its application for expanded use of the oral cancer drug Welireg.

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 ...

A pheochromocytoma is an intra-adrenal paraganglioma ... only follow reasonable clinical and/or biochemical evidence of a tumor Although CT and MRI have excellent sensitivity for detecting ...

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