Merck Gets FDA Priority Review of Welireg

MRK's sNDA for Welireg in Rare Tumors Gets FDA's Priority Tag
Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral HIF-2α inhibitor, Welireg (belzutifan), for a new indication. The sNDA is seeking approval of Welireg for treating advanced,
Merck’s Welireg sNDA accepted for priority review in PPGL
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for Welireg (belzutifan), Merck & Co’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor,
Merck’s WELIREG Accepted for Priority Review by FDA for Pheochromocytoma and Paraganglioma
The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.
Merck's Welireg oral cancer drug gets FDA priority review
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 WELIREG gets USFDA priority review for 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) has accepted for priority review a supplemental new drug
FDA Grants Priority Review to Merck’s Welireg for Advanced, Unresectable, or Metastatic Pheochromocytoma, Paraganglioma
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 paraganglioma.
Merck Gets FDA Priority Review of Welireg in Rare Adrenal Tumors
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 adrenal glands.
FDA Accepts sNDA for Welireg in Advanced 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.
US FDA grants priority review status to Merck’s sNDA for Welireg to treat patients with advanced pheochromocytoma and paraganglioma
Rahway, New Jersey Tuesday, January 28, 2025, 10:00 Hrs [IST]
Merck: FDA grants priority review to sNDA for Welireg
Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s
Merck gets priority review for Welireg for PPGL
The FDA has accepted Merck's (MRK) supplemental NDA with priority review for its drug Welireg for the treatment of a rare type of adrenal gland tumors. Read more here.
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Regulatory tracker: Merck's Welireg picks up FDA priority review in rare tumor bid
Welireg generated $139 million in sales during 2024’s third quarter and is the only approved HIF-2α inhibitor in the U.S. Merck’s application in PPGL is based on objective response rate and ...
Merck announces $0.81 dividend and $10 billion buyback
Co., Inc. (NYSE:MRK), a global healthcare leader, declared on Monday a quarterly dividend and a substantial stock repurchase ...