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MRK's sNDA for Welireg in Rare Tumors Gets FDA's Priority Tag
Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral ...
Cure Today3d
FDA Accepts sNDA for Welireg in Advanced Pheochromocytoma and Paraganglioma
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...
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 ...
Managed Healthcare Executive9d
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines ...
Targeted Oncology4d
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.
Scilex to file SNDA with FDA for ELYXYB
Scilex (SCLX) announced that it will be filing today of a Supplemental New Drug Application, SNDA, with the FDA for ELYXYB in acute pain ...
The Pharma Letter4d
Merck’s Welireg sNDA accepted for priority review in PPGL
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for ...
Pharmabiz13d
Amgen receives US FDA approval for Lumakras in combo with Vectibix for chemorefractory KRAS G12C-mutated metastatic colorectal cancer
Amgen receives US FDA approval for Lumakras in combo with Vectibix for chemorefractory KRAS G12C-mutated metastatic colorectal cancer: Thousand Oaks, California Monday, January 20 ...