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FDA extends review period for Applied Therapeutics’ govorestat NDA
The NDA is supported by data demonstrating a quick ... and we will continue to work closely with the FDA throughout the review process. “During this time, we are committed to maintaining the ...
Renal & Urology News14h
Nasal Spray Formulation of Bumetanide Under FDA Review
The FDA has accepted for review the NDA for bumetanide nasal spray for edema associated with CHF, as well as hepatic and renal disease.
Nasdaq25d
Fortress, Cyprium announce FDA acceptance, priority review of NDA for CUTX-101
The NDA has been granted Priority Review and assigned a Prescription Drug User Fee Act target action date of June 30, 2025. TipRanks is the most comprehensive data set of sell side analysts and ...
Yahoo Finance23d
Vanda's Letter to FDA Commissioner Highlights Faulty Gastroparesis NDA Review
WASHINGTON, Jan. 8, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) letter to FDA Commissioner highlights faulty gastroparesis NDA review. Vanda Logo (PRNewsfoto/Vanda ...
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FDA extends review of Fortress Biotech's CUTX-101 drug
The NDA for CUTX-101 ... The extension of the FDA's review period is a critical step in the regulatory process, as CUTX-101 could potentially provide a new treatment option for individuals ...
Nasdaq29d
VSTM Up as NDA for Ovarian Cancer Combo Gets FDA's Priority Review Tag
Shares of Verastem Oncology VSTM rallied 40.9% on Tuesday after it announced that the FDA has accepted the new drug application (NDA) for its avutometinib/defactinib ...