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

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

The FDA accepts and grants priority review to Merck's sNDA for Welireg to treat advanced pheochromocytoma and paraganglioma.

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 ...

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

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

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 ...

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

Ghazal continued: "The regulator's long-awaited guidance on age assurance means adult content providers now have the clarity they need to get their houses in order and put in place robust and reliable ...

The global, dose-ranging AGAVE-201 trial evaluated the efficacy, safety, and tolerability of Niktimvo in 241 adult and pediatric patients. Enrollment criteria included having experienced disease ...

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