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

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

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.

Priority review for Welireg is based on data from the Phase II LITESPARK-015 trial, which showed promising response rates in ...

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

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 ...

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

Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its Welireg oral cancer drug in patients with rare tumors that form in and around the ...

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

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 ...