FDA grants priority review to sNDA for Welireg

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.
FDA Grants Priority Review to Merck’s Welireg for Advanced, Unresectable, or Metastatic Pheochromocytoma, 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 paraganglioma.
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 include its use for the treatment of the rare cancer pheochromocytoma and paraganglioma (PPGL).
Merck: FDA grants priority review to sNDA for Welireg
Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s
Merck Gets FDA Priority Review of Welireg in Rare Adrenal Tumors
Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its Welireg oral cancer drug in patients with rare tumors that form in and around the adrenal glands.
Merck gets priority review for Welireg for PPGL
The FDA has accepted Merck's (NYSE:MRK) supplemental New Drug Application with priority review for its drug Welireg, also known as belzutifan, for the treatment of a rare type of adrenal gland tumors.
Merck's Welireg oral cancer drug gets FDA priority review
Merck & Co (NYSE:MRK) said on Monday that the U.S. Food and Drug Administration (FDA) has granted priority review to its application for expanded use of the oral cancer drug Welireg.
Monthly Prescribing Reference1d
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 ...
Replimune Group’s Promising Outlook: FDA Priority Review and Positive Trial Data Support Buy Rating
Leerink Partners analyst Jonathan Chang has reiterated their bullish stance on REPL stock, giving a Buy rating yesterday.Invest with ...
rheumatologyadvisor6d
Nipocalimab Gets Priority Review for Generalized Myasthenia Gravis
The FDA has granted Priority Review to nipocalimab for the treatment of antibody positive patients with generalized myasthenia gravis.
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Belzutifan Gets Priority Review for Advanced Pheochromocytoma and Paraganglioma
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...