Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral ...

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 ...

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

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 ...

Finally, new animal models of familial and metastatic pheochromocytoma or paraganglioma will provide essential tools to test new approaches for diagnosis and treatment of tumors and the ...

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

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

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 ...

The sNDA is seeking approval of Welireg for treating advanced, unresectable, or metastatic pheochromocytoma and paraganglioma (PPGL) in adult and pediatric patients aged 12 years and above.

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