Zacks.com on MSN4d
MRK'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.
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for ...
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date ...
Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...
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ITCI Submits sNDA to the FDA for Expanded Use of Caplyta in MDDThe 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 ...
(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 ...
1 Day SNDA -1.84% DJIA -0.32% Russell 2K -0.30% Health Care/Life Sciences -0.52% ...
Zacks.com on MSN23d
FDA Accepts Agios' sNDA for Pyrukynd in ThalassemiaIf approved, AGIO's Pyrukynd will be the first oral therapy for all thalassemia subtypes. A final decision is expected by Sep. 7.
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