The FDA has accepted the application for belzutifan for advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.

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

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 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 ...

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

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

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 ...

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