“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 disease,” ...
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 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 ...
Rahway, New Jersey Tuesday, January 28, 2025, 10:00 Hrs [IST] ...
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for ...
GlobalData on MSN12d
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 ...
Zacks.com on MSN11d
MRK's sNDA for Welireg in Rare Tumors Gets FDA's Priority TagThe FDA accepts and grants priority review to Merck's sNDA for Welireg to treat advanced pheochromocytoma and paraganglioma.
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 ...
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