The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.
A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application for SL1009 (sodium dichloroacetate oral solution) for the treatment of pyruvate dehydrogenase complex ...
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 FDA has accepted the application for belzutifan for advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...
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CMRX Stock Skyrockets in 3 Months: Here's What You Should KnowChimerix stock surges 324% in three months following NDA submission for high-grade glioma drug, dordaviprone, for accelerated ...
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and paraganglioma.
today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) seeking approval of WELIREG ® (belzutifan), Merck’s oral hypoxia ...
announced the US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) seeking approval of Welireg (belzutifan), Merck’s oral hypoxia-inducible ...
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