Hosted on MSN4d
MSD wins FDA priority review for Welireg in rare endocrine cancer
The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...
Hosted on MSN3d
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 ...
Cure Today2d
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 Letter3d
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 ...
Pharm Exec4d
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 ...
Endocrinology Advisor4d
Belzutifan Gets Priority Review for Advanced Pheochromocytoma and Paraganglioma
The FDA has accepted the application for belzutifan for advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
Nature3y
First FDA-approved treatment for an ultra-rare disease
“PPGL includes all of these tumours; they can arise anywhere from the base of the skull down to the bladder.” As PPGLs are rare, obtaining evidence to prove the safety and efficacy of a ...
Seeking Alpha4d
Merck gets priority review for Welireg for PPGL
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 ...
Pharmabiz4d
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] ...
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 ...
Nature3y
The first FDA approved treatment for ultra-rare endocrine tumors
Fortunately, there is now an effective treatment available for patients with unresectable, locally advanced or metastatic pheochromocytoma and paraganglioma (PPGL). A recent review in Cancers from ...