Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral HIF-2α inhibitor, Welireg (belzutifan), for a new indication. The sNDA is seeking approval of Welireg for treating advanced,

The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for Welireg (belzutifan), Merck & Co’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor,

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

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.

Rahway: Merck, known as MSD outside of the United States and Canada, has announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug

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 paraganglioma.

The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic 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 type of adrenal gland tumors. Read more here.