Targeted Oncology5d
FDA Grants Belzutifan Priority Review For Advanced 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 American Journal of Managed Care2h
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
BioSpace13h
What Trump’s Second Term Could Mean for PDUFA’s Future
Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...
Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
Monthly Prescribing Reference5d
Novel Therapy for Pyruvate Dehydrogenase Complex Deficiency Gets Priority Review
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 ...
Endocrinology Advisor6d
Belzutifan Gets Priority Review for Advanced Pheochromocytoma and Paraganglioma
The FDA has accepted the application for belzutifan for advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
PharmiWeb6d
FDA Grants Priority Review to Merck’s Application…
has accepted for priority review a supplemental new drug application (sNDA) seeking approval of WELIREG ® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the ...
Hosted on MSN6d
MSD wins FDA priority review for Welireg in rare endocrine cancer
The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...