Researchers have published findings from the phase 2 LITESPARK-003 study of patients with previously untreated advanced clear ...
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Zacks.com on MSNMRK's sNDA for Welireg in Rare Tumors Gets FDA's Priority TagThe FDA accepts and grants priority review to Merck's sNDA for Welireg to treat advanced pheochromocytoma and paraganglioma. A decision is due on May 26, 2025.
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for Welireg (belzutifan), Merck & Co’s oral hypoxia-inducible factor-2 alpha ...
Acceptance based on objective response rate data from the Phase 2 LITESPARK-015 trial evaluating WELIREG in certain patients with advanced PPGL If approved, WELIREG would be the only available therapy ...
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 MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral HIF-2α inhibitor, Welireg (belzutifan), for a new indication. The sNDA is ...
Alan Tan, MD, discusses upcoming trials that could change the landscape of frontline and adjuvant renal cell carcinoma ...
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 ...
Rahway, New Jersey Tuesday, January 28, 2025, 10:00 Hrs [IST] ...
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