The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for ...
The FDA has accepted the application for belzutifan for advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
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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.
The FDA has accepted Merck's (MRK) supplemental NDA with priority review for its drug Welireg for the treatment of a rare ...
Rahway, New Jersey Tuesday, January 28, 2025, 10:00 Hrs [IST] ...
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 ...
“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 ...
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 ...
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