Merck 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 ...

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

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

Currently, Welireg is the only therapy approved in the United States for adult patients with von Hippel-Lindau (VHL) who require therapy as a result of associated renal cell carcinoma (RCC), central ...

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

Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...

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

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 ...

MSD acquired Welireg when it bought Peloton Therapeutics for an upfront payment of $1.05bn in 2019. In August 2021, the drug was first approved by the FDA for the treatment of a rare disorder ...