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 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 ...

MIBG binds to a protein commonly expressed on the surface of PPGL cells, which facilitates the transport of the neurotransmitter norepinephrine. Jimenez notes that this effective tumor-labeling ...

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.

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

for the treatment of a rare type of adrenal gland tumors. Welireg is already approved by the FDA for the treatment of adults with von Hippel-Lindau disease who require therapy for associated renal ...

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

About LITESPARK-015 LITESPARK-015 is an open-label, single-arm, multi-cohort Phase 2 trial (NCT04924075) evaluating the efficacy and safety of WELIREG monotherapy in patients with advanced PPGL ...