The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and paraganglioma.
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.
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MRK's sNDA for Welireg in Rare Tumors Gets FDA's Priority TagMerck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral ...
The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...
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 Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...
The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.
A pheochromocytoma is a type of tumor found in the adrenal glands or certain nerve cells. These tumors are very rare but can cause dramatic symptoms because they tend to secrete large amounts of ...
The panel of experts at the ISP felt strongly that localization of pheochromocytoma or paraganglioma should only be initiated if the clinical evidence for the presence of tumor is reasonably ...
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