Zacks.com on MSN6d
MRK's sNDA for Welireg in Rare Tumors Gets FDA's Priority TagMerck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral ...
Hosted on MSN2mon
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.
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 ...
Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...
Agios Pharmaceuticals AGIO announced that the FDA has accepted its supplemental new drug application (sNDA) seeking label expansion for its sole marketed drug, Pyrukynd, in thalassemia indication.
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines ...
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and paraganglioma.
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for ...
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 supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.
Results that may be inaccessible to you are currently showing.
Hide inaccessible results
Feedback