Hosted on MSN6d
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 MSN5d
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 Today4d
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 ...
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 ...
The Pharma Letter5d
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 ...
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 ...
Endocrinology Advisor6d
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.
Pharm Exec7d
FDA Grants Priority Review to Merck’s Welireg for Advanced, Unresectable, or Metastatic Pheochromocytoma, Paraganglioma
Currently, there are no approved therapies for PPGL in the United States. 1 “Pheochromocytoma and paraganglioma are rare tumors that form in and around the adrenal glands, and currently, there are no ...
Pharmabiz6d
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] ...
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 ...