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 panel of experts at the ISP felt strongly that localization of pheochromocytoma or paraganglioma should only be initiated if the clinical evidence for the presence of tumor is reasonably ...

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

Bilateral optic disc swelling is an important clinical sign that can reflect a variety of inflammatory, infectious, toxic, metabolic, genetic, or vascular conditions, such as hypertension. [1] It ...

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

Low-osmolar, contrast-enhanced CT can be safely used in patients with pheochromocytoma. “This tool will enhance physicians' abilities to diagnose and treat patients with pheochromocytoma ...

Merck & Co (NYSE:MRK) said on Monday that the U.S. Food and Drug Administration (FDA) has granted priority review to its ...

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

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

Monitor HR during therapy. Bronchospastic disease. Pheochromocytoma. Surgery. Diabetes. May mask signs and increase risk for hypoglycemia. Hyperthyroidism. Avoid abrupt cessation. Hepatic impairment.

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