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 ...
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and paraganglioma.
GlobalData on MSN12d
MSD wins FDA priority review for Welireg in rare endocrine cancerThe regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription ...
Zacks.com on MSN11d
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.
However, in the final analysis, the study failed to show a statistically significant increase in overall survival ... treatment of patients with advanced pheochromocytoma and paraganglioma.
Hosted on MSN7d
Pharma Stock Roundup: SNY and RHHBY's Q4 Earnings & MoreSanofi SNY and Roche RHHBY announced their fourth-quarter and full-year 2024 results. Novo Nordisk’s NVO novel obesity ...
focused on the evaluation of postoperative management of patients with pheochromocytoma assessing hemodynamic ... The treatment outcome was a partial response, and the progression free survival of the ...
Overall Survival and CHB-Specific Survival in VHL Disease Patients ... renal cell carcinoma; PHEO, pheochromocytoma; PCL/PNET, pancreatic cystic lesion and pancreatic neuroendocrine tumors.
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