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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 ...
Pharmabiz4d
US FDA grants priority review status to Merck’s sNDA for Welireg to treat patients with advanced pheochromocytoma and paraganglioma
announced the US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) seeking approval of Welireg (belzutifan), Merck’s oral hypoxia-inducible ...
JNJ's SNDA For Spravato Monotherapy Gets FDA Approval For Treatment-Resistant Depression
(RTTNews) - Johnson & Johnson (JNJ), Tuesday announced that the U.S. Food and Drug Administration has approved supplemental New Drug Application or sNDA for Spravato, a monotherapy for adults with ...
Nasdaq1mon
FDA APPROVES ACETADOTE® sNDA
"This FDA approval is a significant ... the administration process, we aim to enhance patient outcomes and reduce the burden on health care providers." FDA-approved sNDA adds a simplified, IV ...
Johnson & Johnson announces FDA approves sNDA for Spravato
Johnson & Johnson announced the U.S. FDA approval of a supplemental New Drug Application for Spravato CIII nasal spray, making this ...
Morningstar11d
SPRAVATO® (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression
TITUSVILLE, N.J., Jan. 21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) ...
Nasdaq4d
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 ... is currently approved in the United States for patients with advanced ...