Merck gets priority review for Welireg

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 gets priority review for Welireg for PPGL
The FDA has accepted Merck's (MRK) supplemental NDA with priority review for its drug Welireg for the treatment of a rare type of adrenal gland tumors. Read more here.
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.
Merck’s WELIREG Accepted for Priority Review by FDA for Pheochromocytoma and Paraganglioma
The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.
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.
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: 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'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.
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Nasal Spray Formulation of Bumetanide Under FDA Review
The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.
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FDA Extends Review of Elamipretide for Barth Syndrome
The FDA has extended the review period for the New Drug Application for elamipretide for the treatment of Barth syndrome.
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Stealth faces another hurdle as FDA delays decision on Barth syndrome drug
The FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.
D.C.'s Vanda Pharmaceuticals battling FDA on multiple fronts
A D.C. drugmaker is fighting the FDA on multiple fronts, from trying protect its intellectual property from generic ...
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FDA Accepts New Drug Application For Taletrectinib in ROS1+ NSCLC
The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell lung cancer. The Food and Drug Administration (FDA) has accepted a new ...
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Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
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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 ...