The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...
The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription ...
The PBM system intentionally blocks lower-cost, FDA-approved biosimilars from being available to patients. Biosimilars are the commonsense, bipartisan solution to out-of-control prescription drug ...
"We are pleased the FDA has accepted our NDA for Bumetanide Nasal Spray," said Benjamin Esque, CEO of Corstasis Therapeutics ...