Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral ...
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...
Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...
The sNDA submission is supported by positive results from two late-stage studies, Studies 501 and 502, that evaluated 42 mg of lumateperone as an adjunctive therapy to antidepressants for MDD ...
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for ...
(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 ...
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 FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.
FDA-approved sNDA adds a simplified, IV NAC dosing regimen to the product prescribing information. New IV NAC dosing regimen is both safe and effective. New dosing regimen aims to minimize ...
1 Day SNDA -1.84% DJIA -0.32% Russell 2K -0.30% Health Care/Life Sciences -0.52% ...