FDA

FDA Grants Belzutifan Priority Review For Advanced Pheochromocytoma and Paraganglioma…

The FDA has granted priority review to a sNDA submitted by Merck seeking belzutifan’s (Welireg) approval for treatment of adult and pediatric patients 12 years of age and older with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.  With this approval, the sNDA has been assigned a target action date of May 26, 2025 under the PDUFA…