Zacks.com on MSN4d
MRK's sNDA for Welireg in Rare Tumors Gets FDA's Priority Tag
The FDA accepts and grants priority review to Merck's sNDA for Welireg to treat advanced pheochromocytoma and paraganglioma.
GlobalData on MSN5d
MSD wins FDA priority review for Welireg in rare endocrine cancer
The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription ...
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 ...
Cure Today3d
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 ...
The Pharma Letter4d
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 ...
Von Hippel-Lindau disease drug Welireg listed on PBS slashing cost by $11,000 a month for patients
The treatment for Simon Goodrich’s disease has been costing $12,000 a month, but there has been a huge development.
Contract Pharma5d
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.
Daily4d
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 ...
Nasdaq4d
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 ...
PharmiWeb4d
FDA Grants Priority Review to Merck’s Application…
Acceptance based on objective response rate data from the Phase 2 LITESPARK-015 trial evaluating WELIREG in certain patients with advanced PPGL If approved, WELIREG would be the only available therapy ...