The FDA has accepted for review the NDA for bumetanide nasal spray for edema associated with CHF, as well as hepatic and renal disease.
today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its novel Bumetanide Nasal Spray (RSQ-777). The FDA has assigned a ...
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), a pharmaceutical company with a market capitalization of $256.56 million and impressive gross profit margins of 93.62%, disclosed through a social media post ...
The FDA has extended the review period for the New Drug Application for elamipretide for the treatment of Barth syndrome.
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date ...
Atara Biotherapeutics’ layoffs could leave the biotech with around 80 employees. The cuts follow news that the FDA rejected ...
The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin’s Sacubitril and ...
Priority review for Welireg is based on data from the Phase II LITESPARK-015 trial, which showed promising response rates in ...
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