The challenge is that unlike clinical outcomes and drug tolerability ... chart review studies, there are some exceptions. The need for informed consent can prolong study timelines as well as ...

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

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 ...

The FDA has accepted the application for belzutifan for advanced, unresectable, 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 ...

The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...

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 ...

Here is a select list of cancer therapies approved by the FDA throughout the month of January, featuring patient populations ...