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

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 ...

Rahway, New Jersey Tuesday, January 28, 2025, 10:00 Hrs [IST] ...

The panel of experts at the ISP felt strongly that localization of pheochromocytoma or paraganglioma ... tumors -- including recently discovered disease-causing genes (see below) -- there are ...

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 ...

At the age of 52 years, a man had begun to exhibit jaw tremor, decreased vocal volume, reduced facial expression and muscle pain, all of which suggested a diagnosis of Parkinson disease (PD).

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 ...

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

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

Conduction disorders (eg, Wolff-Parkinson-White). Monitor HR during therapy. Bronchospastic disease. Pheochromocytoma. Surgery. Diabetes. May mask signs and increase risk for hypoglycemia.

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