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 2004 WHO classification of endocrine tumors defines pheochromocytoma as a tumor arising from catecholamine-producing chromaffin cells in the adrenal medulla -- an intra-adrenal paraganglioma.

The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.

The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...

On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...

The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and 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 ...

Rahway: Merck, known as MSD outside of the United States and Canada, has announced the U.S. Food and Drug Administration (FDA ...

MEN type 2B is a very rare disorder and can cause medullary thyroid cancer, pheochromocytoma, and lesions on the tongue and lips (mucosal neuromas). Familial paraganglioma-pheochromocytoma syndrome is ...

The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for ...

Merck & Co (NYSE:MRK) said on Monday that the U.S. Food and Drug Administration (FDA) has granted priority review to its application for expanded use of the oral cancer drug Welireg.

The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.